from docx import Document
from docx.shared import Pt, Inches, RGBColor
from docx.enum.text import WD_ALIGN_PARAGRAPH
from docx.enum.table import WD_TABLE_ALIGNMENT
from docx.oxml.ns import qn
from docx.oxml import OxmlElement
import copy

doc = Document()

# ---- Page margins ----
section = doc.sections[0]
section.top_margin = Inches(1)
section.bottom_margin = Inches(1)
section.left_margin = Inches(1.2)
section.right_margin = Inches(1)

# ---- Default style ----
normal_style = doc.styles["Normal"]
normal_style.font.name = "Times New Roman"
normal_style.font.size = Pt(12)

def set_font(run, bold=False, size=12, color=None):
    run.font.name = "Times New Roman"
    run.font.size = Pt(size)
    run.font.bold = bold
    if color:
        run.font.color.rgb = RGBColor(*color)

def add_heading(text, level=1, center=False):
    p = doc.add_paragraph()
    p.paragraph_format.space_before = Pt(8)
    p.paragraph_format.space_after = Pt(4)
    if center:
        p.alignment = WD_ALIGN_PARAGRAPH.CENTER
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.bold = True
    if level == 1:
        run.font.size = Pt(14)
    elif level == 2:
        run.font.size = Pt(13)
    else:
        run.font.size = Pt(12)
    return p

def add_para(text, bold=False, indent=False, space_after=6):
    p = doc.add_paragraph()
    p.paragraph_format.space_after = Pt(space_after)
    if indent:
        p.paragraph_format.left_indent = Inches(0.3)
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.size = Pt(12)
    run.font.bold = bold
    return p

def add_label_value(label, value=""):
    p = doc.add_paragraph()
    p.paragraph_format.space_after = Pt(4)
    r1 = p.add_run(label + ": ")
    r1.font.bold = True
    r1.font.name = "Times New Roman"
    r1.font.size = Pt(12)
    r2 = p.add_run(value)
    r2.font.name = "Times New Roman"
    r2.font.size = Pt(12)

def add_bullet(text):
    p = doc.add_paragraph(style="List Bullet")
    p.paragraph_format.space_after = Pt(3)
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.size = Pt(12)

def add_table_row(table, cells_data, bold_first=False):
    row = table.add_row()
    for i, text in enumerate(cells_data):
        cell = row.cells[i]
        cell.text = text
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"
                run.font.size = Pt(11)
                if i == 0 and bold_first:
                    run.font.bold = True

def shade_row(row, hex_color="D9E1F2"):
    for cell in row.cells:
        tc = cell._tc
        tcPr = tc.get_or_add_tcPr()
        shd = OxmlElement('w:shd')
        shd.set(qn('w:val'), 'clear')
        shd.set(qn('w:color'), 'auto')
        shd.set(qn('w:fill'), hex_color)
        tcPr.append(shd)

# ======================================================
# HEADER
# ======================================================
p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.CENTER
r = p.add_run("Faculty of Medicine – Meenakshi Medical College Hospital & Research Institute")
r.font.name = "Times New Roman"; r.font.size = Pt(13); r.font.bold = True

p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.CENTER
r = p.add_run("Institutional Ethics Committee – Human Studies")
r.font.name = "Times New Roman"; r.font.size = Pt(12); r.font.bold = True

doc.add_paragraph()

# ======================================================
# COVER LETTER
# ======================================================
add_heading("COVER LETTER", level=2, center=True)
doc.add_paragraph()

for line in ["From", "Dr. [Candidate Name]", "[Designation / Year]", "Department of Obstetrics & Gynaecology", "MMCHRI, Kanchipuram"]:
    p = doc.add_paragraph(line)
    p.paragraph_format.space_after = Pt(2)
    for run in p.runs:
        run.font.name = "Times New Roman"; run.font.size = Pt(12)

doc.add_paragraph()
for line in ["To", "The Chairperson,", "Institutional Ethics Committee,", "MMCHRI, Kanchipuram"]:
    p = doc.add_paragraph(line)
    p.paragraph_format.space_after = Pt(2)
    for run in p.runs:
        run.font.name = "Times New Roman"; run.font.size = Pt(12)

doc.add_paragraph()
add_para("Through Proper Channel", bold=False)
doc.add_paragraph()
add_para("Respected Sir/Madam,")

add_para(
    'Sub: Request for ethical clearance for the study – '
    '"Intraoperative Complications and Postoperative Recovery in Non-Descent Vaginal '
    'Hysterectomy and Total Laparoscopic Hysterectomy: A Retrospective Study".'
)

body_text = (
    "I, Dr. [Candidate Name], [PhD/PG/Undergraduate/Faculty] of Meenakshi Medical College "
    "Hospital & Research Institute, wish to undertake a project titled "
    "\"Intraoperative Complications and Postoperative Recovery in Non-Descent Vaginal "
    "Hysterectomy (NDVH) and Total Laparoscopic Hysterectomy (TLH): A Retrospective Study\" "
    "under the guidance of Dr. [Guide Name], [Designation], Department of Obstetrics & "
    "Gynaecology, MMCHRI. A copy of the study proposal has been attached herewith. I "
    "kindly request you to grant ethical clearance and approval to conduct this study. "
    "Please do the needful."
)
add_para(body_text)
doc.add_paragraph()
add_para("Thanking You,")
add_para("Yours sincerely,")
doc.add_paragraph()

p = doc.add_paragraph()
r1 = p.add_run("Signature of the Guide                        ")
r1.font.name = "Times New Roman"; r1.font.size = Pt(12)
r2 = p.add_run("Signature of the Candidate / Investigator")
r2.font.name = "Times New Roman"; r2.font.size = Pt(12)

p2 = doc.add_paragraph()
r3 = p2.add_run("Signature of the HOD")
r3.font.name = "Times New Roman"; r3.font.size = Pt(12)

doc.add_page_break()

# ======================================================
# SECTION A
# ======================================================
add_heading("SECTION A – BASIC INFORMATION", level=1, center=True)

# Table for IEC ref and project type
t = doc.add_table(rows=1, cols=2)
t.style = "Table Grid"
t.cell(0,0).text = "IEC Reference No.: _____________"
t.cell(0,1).text = "Project Type: PG Dissertation"
for row in t.rows:
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)
doc.add_paragraph()

add_label_value("Title of Research Proposal",
    "Intraoperative Complications and Postoperative Recovery in Non-Descent Vaginal "
    "Hysterectomy (NDVH) and Total Laparoscopic Hysterectomy (TLH): A Retrospective "
    "Comparative Study at MMCHRI, Kanchipuram")

add_heading("Details of Investigators:", level=3)

# Investigator table
inv_table = doc.add_table(rows=1, cols=3)
inv_table.style = "Table Grid"
hdr = inv_table.rows[0].cells
hdr[0].text = "Name"
hdr[1].text = "Qualification / Designation / Department"
hdr[2].text = "Address for Communication"
shade_row(inv_table.rows[0], "BDD7EE")
for cell in hdr:
    for p in cell.paragraphs:
        for run in p.runs:
            run.font.bold = True; run.font.name = "Times New Roman"; run.font.size = Pt(11)

for role, name, qual, addr in [
    ("Principal Investigator", "Dr. [Name]",
     "Postgraduate Resident, Dept. of OBG",
     "MMCHRI, Kanchipuram\nMob: _______\nEmail: _______"),
    ("Guide / Co-investigator", "Dr. [Guide Name]",
     "Assistant/Associate Professor, Dept. of OBG",
     "MMCHRI, Kanchipuram\nMob: _______\nEmail: _______"),
]:
    row = inv_table.add_row()
    row.cells[0].text = name + f"\n({role})"
    row.cells[1].text = qual
    row.cells[2].text = addr
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
add_label_value("Duration of the Study", "01 January 2022 – 31 December 2024 (3 years retrospective)")
add_label_value("Date of Submission", "[Date]")

add_heading("Funding Details & Budget:", level=3)
add_para("  \u2611 Self-funded     \u25a1 Institutional funding     \u25a1 Funding agency", indent=True)
add_label_value("Total Estimated Budget", "Rs. 10,000/- (Self-funded; no external funding)")

doc.add_page_break()

# ======================================================
# SECTION B
# ======================================================
add_heading("SECTION B – RESEARCH RELATED INFORMATION", level=1, center=True)

b_table = doc.add_table(rows=0, cols=2)
b_table.style = "Table Grid"

rows_data = [
    ("1. Type of Study", "\u2611 Retrospective   \u2611 Quantitative   \u2611 Clinical\n"
                          "\u2611 Single centre   \u2611 Comparative"),
    ("2. Study Design", "\u2611 Retrospective Cohort (record-based comparative study)"),
    ("3. Status of Review", "\u2611 New submission"),
    ("4. Clinical Trial", "Not applicable (retrospective record review; no intervention)"),
    ("5. Drug/Device involved?", "Not applicable"),
    ("6. DCGI approval required?", "Not applicable"),
]
for label, value in rows_data:
    row = b_table.add_row()
    row.cells[0].text = label
    row.cells[1].text = value
    row.cells[0].paragraphs[0].runs[0].font.bold = True
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_page_break()

# ======================================================
# SECTION C
# ======================================================
add_heading("SECTION C – DETAILED RESEARCH PROPOSAL", level=1, center=True)

# ---- Title ----
add_heading("1. Title of the Project", level=2)
add_para(
    "Intraoperative Complications and Postoperative Recovery in Non-Descent Vaginal "
    "Hysterectomy (NDVH) and Total Laparoscopic Hysterectomy (TLH): "
    "A Retrospective Comparative Study",
    bold=True
)

# ---- Background ----
add_heading("2. Background / Introduction", level=2)
intro = [
    "Hysterectomy is the most commonly performed major gynaecological surgery worldwide, "
    "second only to caesarean section. It is performed for a variety of benign conditions "
    "including uterine fibroids (leiomyomata), dysfunctional uterine bleeding (DUB), "
    "adenomyosis, endometriosis, and chronic pelvic pain. Globally, more than 600,000 "
    "hysterectomies are performed annually in the United States alone, and the burden in "
    "developing countries, including India, is equally substantial.",

    "Three primary surgical routes are employed: total abdominal hysterectomy (TAH), "
    "non-descent vaginal hysterectomy (NDVH), and total laparoscopic hysterectomy (TLH). "
    "Historically, the abdominal route was dominant; however, minimally invasive approaches "
    "have gained widespread acceptance owing to their association with reduced morbidity and "
    "faster recovery. Non-descent vaginal hysterectomy refers to vaginal removal of the uterus "
    "in the absence of uterine prolapse, and has been shown to be safe and effective for "
    "selected benign indications. Total laparoscopic hysterectomy, where the entire procedure "
    "including vault closure is performed laparoscopically, represents the latest evolution of "
    "minimally invasive surgery.",

    "Current evidence, including the landmark Cochrane systematic review by Aarts et al. (2015) "
    "and the meta-analysis by Sandberg et al. (2017) comparing TLH and vaginal hysterectomy in "
    "24 studies, demonstrates broadly similar complication profiles. However, differences "
    "persist in operative time, blood loss, analgesic requirements, hospital stay, and "
    "specific complications such as vaginal cuff dehiscence. Vaginal hysterectomy was "
    "associated with shorter operative time and lower rate of cuff dehiscence, while TLH was "
    "associated with lower postoperative pain scores and shorter analgesic requirement.",

    "In the Indian context, where institutional factors, surgeon skill-mix, patient "
    "demographics, and uterine characteristics (fibroid bulk, adhesions, prior surgery) "
    "may differ from Western populations, institutional retrospective data are invaluable. "
    "There is a paucity of published data from South Indian tertiary care centres comparing "
    "NDVH and TLH with respect to specific intraoperative complications (bladder, bowel, "
    "ureteric and vascular injuries; conversion rates; estimated blood loss) and "
    "postoperative recovery parameters (fever, vault complications, urinary tract infection, "
    "analgesic use, return of bowel function, and length of stay). This retrospective study "
    "at MMCHRI aims to bridge that gap."
]
for text in intro:
    add_para(text, space_after=8)

# ---- Objectives ----
add_heading("3. Objectives", level=2)
add_para("Primary Objective:", bold=True)
add_bullet(
    "To compare the intraoperative complications of Non-Descent Vaginal Hysterectomy (NDVH) "
    "and Total Laparoscopic Hysterectomy (TLH) in patients undergoing surgery for benign "
    "uterine conditions at MMCHRI."
)
add_para("Secondary Objectives:", bold=True)
for obj in [
    "To compare postoperative recovery parameters (hospital stay, fever, urinary tract infection, "
    "vault complications, analgesic requirement, return to normal activity) between NDVH and TLH.",
    "To compare intraoperative blood loss, operative time, and conversion rates between the two groups.",
    "To identify factors predictive of complications in each surgical approach.",
    "To assess the overall safety and feasibility of each approach based on institutional data.",
]:
    add_bullet(obj)

# ---- Literature Review ----
add_heading("4. Brief Review of Literature", level=2)
add_para(
    "A minimum of five relevant references are reviewed below in chronological order, "
    "with emphasis on key findings and research gaps addressed by the present study:"
)

reviews = [
    ("Aarts JWM et al. (2015)", "Multiple countries (Cochrane Review)", "Women undergoing hysterectomy for benign conditions",
     "In this landmark Cochrane systematic review of 47 RCTs (4,483 women), vaginal hysterectomy "
     "was confirmed as the surgical route of choice for benign disease, with fewer complications "
     "and faster recovery than abdominal hysterectomy. Where vaginal hysterectomy was not feasible, "
     "laparoscopic hysterectomy was preferred over abdominal. Research gap: most trials did not "
     "separately analyse NDVH versus TLH, and Indian-context data were absent."),
    ("Sandberg EM et al. (2017)", "International (meta-analysis, 24 studies)", "Women undergoing TLH vs. VH for benign or low-grade malignancy",
     "No difference was found in overall major or minor complications (OR 1.24 and 0.83 respectively). "
     "VH had shorter operative time (MD 42 min shorter), lower vaginal cuff dehiscence rate "
     "(OR 6.28 favouring VH), and lower conversion rate. TLH was associated with lower postoperative "
     "pain scores (MD -1.08 VAS) and shorter analgesic requirement. Research gap: observational "
     "institutional data from India lacking; confounders like uterine size not always controlled."),
    ("Tiwari KD et al. (2022)", "Kathmandu, Nepal", "70 women randomly allocated to NDVH (n=35) vs. TAH (n=35)",
     "NDVH was associated with significantly lower median blood loss (p=0.033), shorter hospital stay "
     "(p=0.005), and lower pain scores at discharge and follow-up (p=0.0005). Overall complication "
     "rates were not statistically significant between groups. Research gap: compared NDVH with TAH, "
     "not TLH; single-centre; small sample."),
    ("Wasim T et al. (2024)", "Pakistan (tertiary care hospital)", "Women undergoing vaginal hysterectomy",
     "Reviewed vaginal hysterectomy outcomes at a South Asian tertiary centre, confirming safety "
     "and feasibility in low-resource settings. Bladder injury was the most common intraoperative "
     "complication. Research gap: no laparoscopic comparator group; retrospective data only."),
    ("Berek JS & Novak E (Berek & Novak's Gynecology, 2020)", "Evidence-based textbook review", "All women undergoing hysterectomy",
     "Affirmed vaginal hysterectomy as the preferred route when feasible. Noted that with evidence-based "
     "guidelines, proportion of hysterectomies performed vaginally can exceed 90%. Laparoscopic "
     "hysterectomy associated with increased cost but lower postoperative pain. Research gap: "
     "Institutional audits from developing countries needed to inform local practice guidelines."),
]

lit_table = doc.add_table(rows=1, cols=4)
lit_table.style = "Table Grid"
hdr = lit_table.rows[0].cells
for i, h in enumerate(["Authors (Year)", "Place", "Population", "Key Findings & Research Gaps"]):
    hdr[i].text = h
    hdr[i].paragraphs[0].runs[0].font.bold = True
    hdr[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    hdr[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(lit_table.rows[0], "BDD7EE")

for auth, place, pop, finding in reviews:
    row = lit_table.add_row()
    for i, text in enumerate([auth, place, pop, finding]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- Methods ----
add_heading("5. Materials & Methods", level=2)

add_label_value("Study Design", "Retrospective comparative study")
add_label_value("Study Setting",
    "Department of Obstetrics & Gynaecology, Meenakshi Medical College Hospital & Research "
    "Institute (MMCHRI), Kanchipuram, Tamil Nadu – a tertiary care teaching hospital")
add_label_value("Study Duration",
    "Three years: 01 January 2022 to 31 December 2024 "
    "(retrospective review of case records from this period)")
add_label_value("Study Population",
    "All women who underwent NDVH or TLH for benign uterine indications during the study period "
    "at MMCHRI")

add_heading("Inclusion Criteria:", level=3)
for c in [
    "Women who underwent NDVH or TLH for benign gynaecological conditions (uterine fibroids, "
    "DUB, adenomyosis, endometriosis, chronic pelvic pain) during the study period",
    "Age 18–70 years",
    "Complete operative and postoperative records available",
    "Uterine size up to 16 weeks gestational equivalent",
]:
    add_bullet(c)

add_heading("Exclusion Criteria:", level=3)
for c in [
    "Hysterectomy performed for malignant or pre-malignant conditions",
    "Concurrent procedures not related to hysterectomy (e.g., Burch colposuspension, "
    "sacrocolpopexy) that significantly alter operative time or recovery",
    "Cases converted from TLH to abdominal hysterectomy (these will be noted separately as "
    "conversion cases but excluded from the primary comparative analysis)",
    "Incomplete case records (missing operative notes, blood loss documentation, or discharge summary)",
    "Hysterectomy for uterine prolapse (prolapse cases are a distinct clinical entity; "
    "NDVH without prolapse = non-descent type as defined in this study)",
]:
    add_bullet(c)

add_heading("Sampling:", level=3)
add_label_value("Sampling Frame",
    "All NDVH and TLH cases performed at MMCHRI from January 2022 to December 2024, "
    "identified from the Operation Theatre register and hospital MRD (Medical Records Department)")
add_label_value("Sampling Method",
    "Total enumeration (census sampling) – all eligible cases meeting inclusion criteria will be included")
add_label_value("Sample Size Estimation",
    "Based on the meta-analysis by Sandberg et al. (2017), the mean operative time difference "
    "between TLH and VH was 42 minutes (SD ~30 min). Using a two-sample t-test formula:\n"
    "n = 2[(Z\u03b1/2 + Z\u03b2)² × \u03c3²] / d²\n"
    "Where Z\u03b1/2 = 1.96 (\u03b1=0.05), Z\u03b2 = 0.84 (power 80%), \u03c3 = 30 min, d = 15 min (clinically meaningful difference)\n"
    "n = 2 × [(1.96+0.84)² × 900] / 225 = 2 × 7.84 × 900 / 225 = ~63 per group\n"
    "Minimum required: 63 per group (126 total). A 10% addition for incomplete records: ~70 per group.\n"
    "Expected available cases based on institutional volume: ~80–100 per group over 3 years.")

add_heading("Study Tools / Data Collection Instrument:", level=3)
add_para(
    "A structured data extraction proforma will be used to collect information from case records, "
    "operation theatre registers, anaesthesia records, and discharge summaries. "
    "No patient contact is required (retrospective design)."
)
add_para("The proforma will include the following sections:", bold=True)
for sec in [
    "Section 1 – Patient Demographics: Age, BMI, parity, previous abdominal/pelvic surgery, co-morbidities",
    "Section 2 – Preoperative Details: Indication for surgery, uterine size (by USG), haemoglobin, ASA grade",
    "Section 3 – Intraoperative Parameters: Type of surgery (NDVH/TLH), operative time (incision to closure), "
    "estimated blood loss (mL), requirement for blood transfusion, intraoperative complications "
    "(bladder injury, bowel injury, ureteric injury, vascular injury, anaesthetic complications), "
    "conversion to laparotomy",
    "Section 4 – Postoperative Parameters: Duration of hospital stay (days), postoperative fever "
    "(temp >38°C beyond 24h), wound/vault complications (vault dehiscence, vault haematoma, vault infection), "
    "urinary complications (UTI, urinary retention), return of bowel function (first flatus time), "
    "analgesic requirement (number of doses / type), readmission within 30 days",
    "Section 5 – Histopathology: Final pathological diagnosis",
]:
    add_bullet(sec)

add_heading("List of Variables and Their Measurement:", level=3)
var_table = doc.add_table(rows=1, cols=4)
var_table.style = "Table Grid"
for i, h in enumerate(["S.No.", "Variable", "Type", "Measurement / Scale"]):
    var_table.rows[0].cells[i].text = h
    var_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    var_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    var_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(var_table.rows[0], "BDD7EE")

var_rows = [
    ("1", "Type of surgery (NDVH / TLH)", "Independent (nominal)", "Categorical: NDVH or TLH"),
    ("2", "Age", "Confounding (continuous)", "Years"),
    ("3", "BMI", "Confounding (continuous)", "kg/m²"),
    ("4", "Parity", "Confounding (ordinal)", "Number of deliveries"),
    ("5", "Uterine size", "Confounding (ordinal)", "Weeks gestational equivalent (USG)"),
    ("6", "Prior abdominal surgery", "Confounding (nominal)", "Yes / No"),
    ("7", "Operative time", "Dependent (continuous)", "Minutes (skin incision to closure)"),
    ("8", "Estimated blood loss", "Dependent (continuous)", "mL (anaesthesia record / surgical note)"),
    ("9", "Blood transfusion", "Dependent (nominal)", "Yes / No; units transfused"),
    ("10", "Intraoperative complication", "Dependent (nominal)", "Type: bladder/bowel/ureter/vascular/other; Yes/No"),
    ("11", "Conversion to laparotomy", "Dependent (nominal)", "Yes / No (TLH group)"),
    ("12", "Hospital stay", "Dependent (continuous)", "Days from surgery to discharge"),
    ("13", "Postoperative fever", "Dependent (nominal)", "Yes / No (>38°C after 24h)"),
    ("14", "Vault complication", "Dependent (nominal)", "Dehiscence / haematoma / infection / None"),
    ("15", "Urinary complication (UTI / retention)", "Dependent (nominal)", "Yes / No"),
    ("16", "Analgesic requirement", "Dependent (continuous/ordinal)", "Number of additional analgesic doses beyond protocol"),
    ("17", "Return of bowel function", "Dependent (continuous)", "Hours to first flatus"),
    ("18", "30-day readmission", "Dependent (nominal)", "Yes / No"),
]
for row_data in var_rows:
    row = var_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

add_heading("Data Collection Procedures:", level=3)
add_para(
    "Following IEC approval, the Principal Investigator will identify all eligible cases from "
    "the Operation Theatre register of the Department of Obstetrics & Gynaecology, MMCHRI, "
    "for the period January 2022 – December 2024. Case records will be retrieved from the MRD "
    "after obtaining permission from the Head of Department and Medical Superintendent. "
    "Data will be extracted onto the structured proforma by the Principal Investigator. "
    "Data entry will be done into Microsoft Excel 2016 and verified by double data entry. "
    "Identifiable patient information will be anonymised using a unique study ID. "
    "Original records will not be removed from the MRD."
)

add_heading("Operational Definitions:", level=3)
for defn in [
    "Non-Descent Vaginal Hysterectomy (NDVH): Vaginal removal of a uterus that has not prolapsed, "
    "performed for benign gynaecological indications.",
    "Total Laparoscopic Hysterectomy (TLH): Hysterectomy in which all steps including vault "
    "closure are performed laparoscopically (Type IV of the AAGL classification).",
    "Intraoperative complication: Any unintended event occurring during the surgical procedure "
    "requiring additional surgical action (bladder injury, bowel injury, ureteric injury, "
    "vascular injury, conversion to laparotomy).",
    "Estimated blood loss (EBL): Blood loss documented in the anaesthetic/operative record in mL.",
    "Postoperative fever: Temperature > 38°C on two occasions more than 24 hours after surgery, "
    "recorded in nursing notes.",
    "Vault dehiscence: Separation of the vaginal cuff, either partial or complete, within 3 months "
    "of surgery, documented on examination or imaging.",
    "Length of stay (LOS): Number of days from the day of surgery to the day of discharge.",
]:
    add_bullet(defn)

add_heading("Data Analysis:", level=3)
add_para(
    "Statistical analysis will be performed using SPSS version 26.0 (IBM Corp., Armonk, NY). "
    "A p-value of <0.05 will be considered statistically significant."
)

stats_table = doc.add_table(rows=1, cols=4)
stats_table.style = "Table Grid"
for i, h in enumerate(["Variable", "Scale", "Descriptive", "Inferential Test"]):
    stats_table.rows[0].cells[i].text = h
    stats_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    stats_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    stats_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(stats_table.rows[0], "BDD7EE")

stat_rows = [
    ("Operative time", "Continuous", "Mean ± SD", "Independent samples t-test / Mann-Whitney U"),
    ("Estimated blood loss", "Continuous", "Mean ± SD / Median (IQR)", "Mann-Whitney U test"),
    ("Hospital stay (LOS)", "Continuous", "Mean ± SD / Median (IQR)", "Independent t-test / Mann-Whitney U"),
    ("Intraoperative complications", "Categorical", "Frequency, %", "Chi-square test / Fisher's exact test"),
    ("Blood transfusion", "Categorical", "Frequency, %", "Chi-square test"),
    ("Conversion rate (TLH)", "Categorical", "Frequency, %", "Descriptive only"),
    ("Postoperative fever", "Categorical", "Frequency, %", "Chi-square test"),
    ("Vault complications", "Categorical", "Frequency, %", "Chi-square / Fisher's exact"),
    ("UTI / urinary retention", "Categorical", "Frequency, %", "Chi-square test"),
    ("Analgesic requirement", "Continuous/Ordinal", "Mean ± SD / Median", "Mann-Whitney U test"),
    ("Return of bowel function", "Continuous", "Mean ± SD", "Independent t-test"),
    ("30-day readmission", "Categorical", "Frequency, %", "Chi-square test"),
    ("Predictors of complications", "Mixed", "OR (95% CI)", "Binary logistic regression"),
]
for row_data in stat_rows:
    row = stats_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

add_heading("Expected Outcomes:", level=3)
expected = [
    "NDVH and TLH will have comparable intraoperative complication rates, "
    "consistent with existing meta-analytic evidence.",
    "TLH is expected to have longer operative times but potentially lower postoperative pain "
    "and comparable or shorter length of stay.",
    "NDVH is expected to have lower cost and shorter operative time.",
    "The study will generate institutional benchmarking data to guide the choice of "
    "hysterectomy route at MMCHRI.",
    "Logistic regression analysis will identify independent predictors of complications "
    "(e.g. BMI, prior surgery, uterine size) to inform preoperative counselling.",
]
for e in expected:
    add_bullet(e)

add_heading("Dummy Tables (Anticipated Results):", level=3)
add_para("Dummy Table 1: Comparison of Intraoperative Parameters", bold=True)
dt1 = doc.add_table(rows=1, cols=3)
dt1.style = "Table Grid"
for i, h in enumerate(["Parameter", "NDVH (n=~75)", "TLH (n=~75)"]):
    dt1.rows[0].cells[i].text = h
    dt1.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    dt1.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    dt1.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(dt1.rows[0], "BDD7EE")
for r in [
    ("Mean operative time (min)", "Mean ± SD", "Mean ± SD"),
    ("Estimated blood loss (mL)", "Median (IQR)", "Median (IQR)"),
    ("Blood transfusion (n, %)", "n (%)", "n (%)"),
    ("Bladder injury (n, %)", "n (%)", "n (%)"),
    ("Ureteric injury (n, %)", "n (%)", "n (%)"),
    ("Bowel injury (n, %)", "n (%)", "n (%)"),
    ("Conversion to laparotomy (n, %)", "NA", "n (%)"),
]:
    row = dt1.add_row()
    for i, text in enumerate(r):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()
add_para("Dummy Table 2: Comparison of Postoperative Recovery Parameters", bold=True)
dt2 = doc.add_table(rows=1, cols=3)
dt2.style = "Table Grid"
for i, h in enumerate(["Parameter", "NDVH (n=~75)", "TLH (n=~75)"]):
    dt2.rows[0].cells[i].text = h
    dt2.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    dt2.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    dt2.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(dt2.rows[0], "BDD7EE")
for r in [
    ("Mean hospital stay (days)", "Mean ± SD", "Mean ± SD"),
    ("Postoperative fever (n, %)", "n (%)", "n (%)"),
    ("Vault dehiscence (n, %)", "n (%)", "n (%)"),
    ("Vault haematoma (n, %)", "n (%)", "n (%)"),
    ("Vault infection (n, %)", "n (%)", "n (%)"),
    ("UTI (n, %)", "n (%)", "n (%)"),
    ("Urinary retention (n, %)", "n (%)", "n (%)"),
    ("Mean return of bowel function (hrs)", "Mean ± SD", "Mean ± SD"),
    ("30-day readmission (n, %)", "n (%)", "n (%)"),
]:
    row = dt2.add_row()
    for i, text in enumerate(r):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- Ethical Considerations ----
add_heading("6. Ethical Considerations", level=2)
for point in [
    "This is a retrospective record-based study. No patient will be contacted, examined, "
    "or subjected to any intervention. Risk to participants is nil.",
    "Vulnerable populations: Not applicable (no vulnerable population will be directly involved; "
    "records of adult women only).",
    "Privacy and confidentiality: All data will be anonymised using a unique study ID. "
    "Patient names and hospital numbers will not appear in the analysis dataset or publications.",
    "Informed consent: Waiver of individual informed consent is requested given the retrospective "
    "nature of the study. No patient contact will occur.",
    "Conflict of interest: None declared.",
    "Risk category: Minimal risk (secondary data analysis from existing records).",
    "Benefits: Institutional benchmarking data; improved surgical decision-making; "
    "no direct benefit to participants.",
    "All regulations: ICMR National Ethical Guidelines for Biomedical and Health Research "
    "involving Human Participants (2017) will be strictly followed.",
]:
    add_bullet(point)

# ---- Implications ----
add_heading("7. Implications of the Study", level=2)
for imp in [
    "Generate first institutional data from MMCHRI comparing NDVH and TLH, informing "
    "local clinical guidelines and surgical training priorities.",
    "Identify modifiable risk factors for intraoperative and postoperative complications "
    "to improve patient counselling.",
    "Provide evidence to support surgeon credentialing and quality improvement initiatives.",
    "Contribute to South Indian / Tamil Nadu-specific data on minimally invasive "
    "hysterectomy outcomes, which are under-represented in global literature.",
    "Findings may support advocacy for expansion of NDVH as a cost-effective, patient-friendly "
    "route in resource-limited settings.",
]:
    add_bullet(imp)

# ---- Budget ----
add_heading("8. Budget", level=2)
bud_table = doc.add_table(rows=1, cols=3)
bud_table.style = "Table Grid"
for i, h in enumerate(["Item", "Details", "Estimated Cost (INR)"]):
    bud_table.rows[0].cells[i].text = h
    bud_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    bud_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    bud_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(bud_table.rows[0], "BDD7EE")
for r in [
    ("Stationery & Printing", "Proformas, printing of case records, registers", "1,500/-"),
    ("Data Entry & Statistical Analysis", "SPSS software (institutional licence)", "Nil (institutional)"),
    ("Photocopying", "Case records, review articles", "2,000/-"),
    ("Miscellaneous", "Binding, submission copies", "1,500/-"),
    ("Total", "", "Rs. 5,000/-"),
]:
    row = bud_table.add_row()
    for i, text in enumerate(r):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)
                if r[0] == "Total":
                    run.font.bold = True

add_para("Source of funding: Self-funded by the principal investigator.", space_after=4)

# ---- Time Frame ----
add_heading("9. Time Frame / Gantt Chart", level=2)
gantt_table = doc.add_table(rows=1, cols=7)
gantt_table.style = "Table Grid"
for i, h in enumerate(["Activity", "Month 1", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6"]):
    gantt_table.rows[0].cells[i].text = h
    gantt_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    gantt_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    gantt_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(10)
shade_row(gantt_table.rows[0], "BDD7EE")
for r in [
    ("IEC submission & approval", "✓", "", "", "", "", ""),
    ("Permission from MRD/HOD", "✓", "✓", "", "", "", ""),
    ("Case identification & record retrieval", "", "✓", "✓", "", "", ""),
    ("Data extraction & entry", "", "", "✓", "✓", "", ""),
    ("Data analysis & interpretation", "", "", "", "✓", "✓", ""),
    ("Report writing & submission", "", "", "", "", "✓", "✓"),
]:
    row = gantt_table.add_row()
    for i, text in enumerate(r):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- References ----
add_heading("10. References (Vancouver Style)", level=2)
refs = [
    "1. Aarts JWM, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BWJ, et al. Surgical approach "
    "to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. "
    "2015;(8):CD003677. doi:10.1002/14651858.CD003677.pub5",

    "2. Sandberg EM, Twijnstra ARH, Driessen SRC, Jansen FW. Total laparoscopic hysterectomy "
    "versus vaginal hysterectomy: a systematic review and meta-analysis. J Minim Invasive Gynecol. "
    "2017;24(2):206–217.e22. doi:10.1016/j.jmig.2016.10.020",

    "3. Tiwari KD, Dangal G, Karki A, Pradhan HK, Shrestha R, Bhattachan K. Clinical outcome "
    "of non-descent vaginal hysterectomy versus abdominal hysterectomy. J Nepal Health Res Counc. "
    "2022;20(2):357–361. doi:10.33314/jnhrc.v20i02.3924",

    "4. Wasim T, Rana GE, Zunair J. A review of vaginal hysterectomies in the gynaecology "
    "department of a tertiary care hospital. J Pak Med Assoc. 2024;74(4):775–778.",

    "5. Berek JS, ed. Berek & Novak's Gynecology. 16th ed. Philadelphia: Wolters Kluwer; 2020. "
    "Chapter 27: Hysterectomy, pp. 1410–1450.",

    "6. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, et al. Surgical approach "
    "to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. "
    "2009;(3):CD003677.",

    "7. Ekanayake C, Pathmeswaran A, Kularatna S. Cost evaluation, quality of life and pelvic "
    "organ function of three approaches to hysterectomy for benign uterine conditions: study "
    "protocol for a randomized controlled trial. Trials. 2017;18(1):564.",

    "8. Agarwal M, Sinha S, Singh S. Vaginal vault closure following total laparoscopic "
    "hysterectomy: laparoscopic versus conventional technique – a comparative study. "
    "Gynecol Minim Invasive Ther. 2024;13(2):75–80.",

    "9. American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 89: "
    "elective and risk-reducing salpingo-oophorectomy. Obstet Gynecol. 2008;111(1):231–241.",

    "10. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and "
    "Health Research Involving Human Participants. New Delhi: ICMR; 2017.",

    "11. Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to "
    "hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. "
    "2006;(2):CD003677.",

    "12. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J, et al. The eVALuate study: "
    "two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, "
    "the other comparing laparoscopic with vaginal hysterectomy. BMJ. 2004;328(7432):129.",
]
for ref in refs:
    p = doc.add_paragraph(ref)
    p.paragraph_format.space_after = Pt(4)
    p.paragraph_format.left_indent = Inches(0.3)
    p.paragraph_format.first_line_indent = Inches(-0.3)
    for run in p.runs:
        run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_page_break()

# ======================================================
# SECTION D
# ======================================================
add_heading("SECTION D – CHECKLIST & DECLARATION", level=1, center=True)
add_heading("Checklist for Attached Documents (3 Copies)", level=2)

chk_table = doc.add_table(rows=1, cols=5)
chk_table.style = "Table Grid"
for i, h in enumerate(["#", "Item", "Yes", "No", "NA"]):
    chk_table.rows[0].cells[i].text = h
    chk_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    chk_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    chk_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(chk_table.rows[0], "BDD7EE")

chk_items = [
    ("1", "Copy of detailed protocol in prescribed format", "✓", "", ""),
    ("2", "Participant information sheet & informed consent (waiver requested)", "", "", "✓"),
    ("3", "Assent form for minors", "", "", "✓ (no minors involved)"),
    ("4", "Proforma / Data extraction instrument (English)", "✓", "", ""),
    ("5", "Brief CV of all investigators", "✓", "", ""),
    ("6", "Agreement letter from MRD / Head of Department", "✓", "", ""),
    ("7", "DCGI / CTRI approval", "", "", "✓ (retrospective record study)"),
    ("8", "Declaration signed by all investigators; forwarded by HOD", "✓", "", ""),
    ("9", "Investigator's brochure", "", "", "✓ (no drug/device)"),
    ("10", "Advertisement / recruitment material", "", "", "✓ (no recruitment)"),
    ("11", "Compensation / reimbursement details", "", "", "✓ (no participant contact)"),
    ("12", "Insurance documents", "", "", "✓ (no participant contact)"),
    ("13", "Other relevant regulatory clearances", "", "", "✓"),
    ("14", "Funding details (externally funded)", "", "", "✓ (self-funded)"),
    ("15", "Soft copy sent to iecmmchri@mmchri.ac.in", "✓", "", ""),
    ("16", "Hard copy submitted to IEC office, Dept of Community Medicine", "✓", "", ""),
]
for row_data in chk_items:
    row = chk_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- Declaration ----
add_heading("Declaration by Investigators", level=2)
decl_items = [
    "I/We certify that the information provided in this application is complete and correct.",
    "I/We confirm that all investigators have approved the submitted version of proposal/related "
    "documents and have contributed substantially to its preparation.",
    "I/We confirm that this study will be conducted in accordance with the latest ICMR National "
    "Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) "
    "and other applicable regulations and guidelines.",
    "I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics "
    "Act 1940 and its Rules 1945 as amended from time to time, GCP guidelines and other "
    "applicable regulations and guidelines.",
    "I/We will comply with all policies and guidelines of MMCHRI and affiliated institutions.",
    "I/We will ensure that personnel performing this study are qualified, appropriately trained "
    "and will adhere to the provisions of the EC approved protocol.",
    "I/We confirm that we shall submit any protocol amendments, significant deviations, "
    "progress reports (if required) and a final report.",
    "I/We agree to submit for publication to a peer-reviewed journal the complete results of "
    "this study within two years of completion.",
    "I/We are aware of the institution's policies regarding scientific misconduct "
    "(Falsification / Fabrication / Plagiarism) and agree to abide by them.",
    "I/We will protect the privacy of participants and assure confidentiality of data.",
    "I/We hereby declare that there is no conflict of interest (Financial / Non-Financial) "
    "with any sponsor and with the outcome of the study.",
]
for item in decl_items:
    add_bullet(item)

doc.add_paragraph()

decl_table = doc.add_table(rows=1, cols=3)
decl_table.style = "Table Grid"
for i, h in enumerate(["Name of Investigator", "Department", "Signature with Date"]):
    decl_table.rows[0].cells[i].text = h
    decl_table.rows[0].cells[i].paragraphs[0].runs[0].font.bold = True
    decl_table.rows[0].cells[i].paragraphs[0].runs[0].font.name = "Times New Roman"
    decl_table.rows[0].cells[i].paragraphs[0].runs[0].font.size = Pt(11)
shade_row(decl_table.rows[0], "BDD7EE")
for _ in range(3):
    row = decl_table.add_row()
    for cell in row.cells:
        cell.text = " "
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(12)

doc.add_paragraph()
p = doc.add_paragraph()
r = p.add_run("Signature of the Head of the Department (with Date & Seal): ________________________")
r.font.name = "Times New Roman"; r.font.size = Pt(12)

doc.add_page_break()

# ======================================================
# ANNEXURE 1 – DATA EXTRACTION PROFORMA
# ======================================================
add_heading("ANNEXURE I – DATA EXTRACTION PROFORMA", level=1, center=True)
add_para(
    "Title: Intraoperative Complications and Postoperative Recovery in NDVH and TLH: "
    "A Retrospective Comparative Study", bold=True
)
add_para("All fields are collected from medical records only. No patient contact.")

add_heading("Section 1: Patient Identification & Demographics", level=3)
for field in [
    "Study ID: ___________",
    "Hospital No. (masked after entry): ___________",
    "Date of surgery: __ / __ / ______",
    "Age (years): _____",
    "BMI (kg/m²): _____",
    "Parity: G___ P___ L___ A___",
    "Menopausal status:  □ Pre-menopausal    □ Post-menopausal",
    "Co-morbidities:  □ Diabetes  □ Hypertension  □ Hypothyroidism  □ Anaemia (Hb < 8 g/dL)  □ Others: _____",
    "Previous abdominal/pelvic surgery:  □ Yes (specify: _______)  □ No",
    "ASA grade:  □ I    □ II    □ III",
]:
    add_para(field, indent=True, space_after=3)

add_heading("Section 2: Preoperative Details", level=3)
for field in [
    "Indication for surgery:  □ Fibroid uterus  □ DUB / AUB  □ Adenomyosis  □ Endometriosis  □ Chronic pelvic pain  □ Others: _____",
    "Uterine size (USG):  □ Normal size  □ 6–10 weeks  □ 10–14 weeks  □ 14–16 weeks",
    "Preoperative Hb (g/dL): _____",
    "Type of surgery performed:  □ NDVH    □ TLH",
    "Anaesthesia:  □ General  □ Spinal  □ Combined spinal-epidural",
]:
    add_para(field, indent=True, space_after=3)

add_heading("Section 3: Intraoperative Parameters", level=3)
for field in [
    "Operative time (skin incision to closure, min): _____",
    "Estimated blood loss (mL): _____",
    "Blood transfusion required:  □ Yes (units: _____)  □ No",
    "Intraoperative complications:",
    "   □ Bladder injury  □ Bowel injury  □ Ureteric injury  □ Vascular injury  □ None",
    "   □ Other (specify): _____",
    "Conversion to laparotomy (TLH only):  □ Yes (reason: _____)  □ No  □ NA (NDVH)",
    "Concurrent procedures:  □ None  □ Salpingectomy  □ Oophorectomy  □ Ovarian cystectomy  □ Others: _____",
]:
    add_para(field, indent=True, space_after=3)

add_heading("Section 4: Postoperative Parameters", level=3)
for field in [
    "Duration of urinary catheterisation (hrs): _____",
    "Time to first oral intake (hrs): _____",
    "Time to first flatus (hrs): _____",
    "Postoperative fever (>38°C after 24h):  □ Yes  □ No",
    "   If yes, day of fever onset: _____",
    "Analgesic requirement beyond protocol:  □ 0 extra doses  □ 1–2 doses  □ >2 doses",
    "Urinary complications:  □ UTI  □ Urinary retention  □ None",
    "Wound / Vault complications:",
    "   □ Vault dehiscence  □ Vault haematoma  □ Vault infection  □ None",
    "Paralytic ileus:  □ Yes  □ No",
    "VTE (DVT / PE):  □ Yes  □ No",
    "Length of hospital stay (days from surgery to discharge): _____",
    "30-day readmission:  □ Yes (reason: _____)  □ No",
]:
    add_para(field, indent=True, space_after=3)

add_heading("Section 5: Histopathology", level=3)
for field in [
    "Final histopathological diagnosis: _____",
    "Uterine weight (grams) if recorded: _____",
]:
    add_para(field, indent=True, space_after=3)

doc.add_page_break()

# ======================================================
# ANNEXURE 2 – CV FORMAT
# ======================================================
add_heading("ANNEXURE II – FORMAT FOR CURRICULUM VITAE OF INVESTIGATOR(S)", level=1, center=True)

cv_table = doc.add_table(rows=0, cols=2)
cv_table.style = "Table Grid"
cv_fields = [
    ("Name", ""),
    ("Present Affiliation", "(Job title, Department & Organisation)"),
    ("Address", ""),
    ("Telephone Number", ""),
    ("Email Address", ""),
    ("Qualifications", ""),
    ("Years of Work Experience (post-PG)", ""),
    ("Previous Affiliations (last 5 years)", ""),
    ("Projects Undertaken (last 5 years)", ""),
    ("Relevant Research Training", "(Ethics Training, GCP, Human Participants Protection, etc. with dates)"),
    ("Relevant Publications (last 5 years)", ""),
]
for label, hint in cv_fields:
    row = cv_table.add_row()
    row.cells[0].text = label
    row.cells[1].text = hint
    for i, cell in enumerate(row.cells):
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"
                run.font.size = Pt(11)
                if i == 0:
                    run.font.bold = True

doc.add_paragraph()
p = doc.add_paragraph()
r1 = p.add_run("Signature: ________________________")
r1.font.name = "Times New Roman"; r1.font.size = Pt(12)
r2 = p.add_run("                    Date: ____________")
r2.font.name = "Times New Roman"; r2.font.size = Pt(12)

# ======================================================
# SAVE
# ======================================================
output_path = "/tmp/workspace/iec-proposal/IEC_Proposal_NDVH_vs_TLH_MMCHRI.docx"
doc.save(output_path)
print(f"Saved: {output_path}")

from docx import Document
from docx.shared import Pt, Inches, RGBColor, Cm
from docx.enum.text import WD_ALIGN_PARAGRAPH
from docx.oxml.ns import qn
from docx.oxml import OxmlElement

doc = Document()

# ---- Page margins ----
section = doc.sections[0]
section.top_margin = Inches(1)
section.bottom_margin = Inches(1)
section.left_margin = Inches(1.2)
section.right_margin = Inches(1)

# ---- Default style ----
normal_style = doc.styles["Normal"]
normal_style.font.name = "Times New Roman"
normal_style.font.size = Pt(12)

# =============== HELPER FUNCTIONS ===============

def shade_row(row, hex_color="BDD7EE"):
    for cell in row.cells:
        tc = cell._tc
        tcPr = tc.get_or_add_tcPr()
        shd = OxmlElement('w:shd')
        shd.set(qn('w:val'), 'clear')
        shd.set(qn('w:color'), 'auto')
        shd.set(qn('w:fill'), hex_color)
        tcPr.append(shd)

def set_cell_text(cell, text, bold=False, size=11, italic=False):
    cell.text = text
    for p in cell.paragraphs:
        p.paragraph_format.space_after = Pt(2)
        for run in p.runs:
            run.font.name = "Times New Roman"
            run.font.size = Pt(size)
            run.font.bold = bold
            run.font.italic = italic

def add_para(text, bold=False, italic=False, center=False, size=12, space_before=0, space_after=6, indent=False):
    p = doc.add_paragraph()
    p.paragraph_format.space_before = Pt(space_before)
    p.paragraph_format.space_after = Pt(space_after)
    if center:
        p.alignment = WD_ALIGN_PARAGRAPH.CENTER
    if indent:
        p.paragraph_format.left_indent = Inches(0.3)
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.size = Pt(size)
    run.font.bold = bold
    run.font.italic = italic
    return p

def add_heading(text, level=1, center=False):
    p = doc.add_paragraph()
    p.paragraph_format.space_before = Pt(10)
    p.paragraph_format.space_after = Pt(4)
    if center:
        p.alignment = WD_ALIGN_PARAGRAPH.CENTER
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.bold = True
    run.font.size = Pt(14 if level == 1 else 13 if level == 2 else 12)
    return p

def add_bullet(text, size=12):
    p = doc.add_paragraph(style="List Bullet")
    p.paragraph_format.space_after = Pt(3)
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.size = Pt(size)

def add_label_value(label, value, size=12):
    p = doc.add_paragraph()
    p.paragraph_format.space_after = Pt(5)
    r1 = p.add_run(label + ": ")
    r1.font.bold = True
    r1.font.name = "Times New Roman"
    r1.font.size = Pt(size)
    r2 = p.add_run(value)
    r2.font.name = "Times New Roman"
    r2.font.size = Pt(size)

def make_table_header(table, headers, shade="1F4E79", text_color="FFFFFF"):
    row = table.rows[0]
    for i, h in enumerate(headers):
        cell = row.cells[i]
        cell.text = h
        tc = cell._tc
        tcPr = tc.get_or_add_tcPr()
        shd = OxmlElement('w:shd')
        shd.set(qn('w:val'), 'clear')
        shd.set(qn('w:color'), 'auto')
        shd.set(qn('w:fill'), shade)
        tcPr.append(shd)
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.bold = True
                run.font.name = "Times New Roman"
                run.font.size = Pt(11)
                run.font.color.rgb = RGBColor.from_string(text_color)

def add_table_data_row(table, cells_data, bold_first=False, size=11):
    row = table.add_row()
    for i, text in enumerate(cells_data):
        cell = row.cells[i]
        cell.text = text
        for p in cell.paragraphs:
            p.paragraph_format.space_after = Pt(2)
            for run in p.runs:
                run.font.name = "Times New Roman"
                run.font.size = Pt(size)
                if i == 0 and bold_first:
                    run.font.bold = True
    return row

def add_sign_line(text):
    p = doc.add_paragraph()
    p.paragraph_format.space_after = Pt(4)
    run = p.add_run(text)
    run.font.name = "Times New Roman"
    run.font.size = Pt(12)


# ======================================================
# INSTITUTION HEADER
# ======================================================
p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.CENTER
r = p.add_run("Faculty of Medicine – Meenakshi Medical College Hospital & Research Institute")
r.font.name = "Times New Roman"; r.font.size = Pt(14); r.font.bold = True

p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.CENTER
r = p.add_run("Institutional Ethics Committee – Human Studies")
r.font.name = "Times New Roman"; r.font.size = Pt(13); r.font.bold = True

doc.add_paragraph()

# ======================================================
# COVER LETTER
# ======================================================
add_heading("COVER LETTER", level=2, center=True)

add_para("Date: 15.07.2026", space_after=8)
add_para("From,")
for line in ["Dr. RAJADURAI. I", "Junior Resident",
             "Department of Dermatology, Venereology and Leprology",
             "Meenakshi Medical College Hospital & Research Institute, Kanchipuram"]:
    add_para(line, space_after=2)

doc.add_paragraph()
add_para("To,")
for line in ["The Chairperson,", "Institutional Ethics Committee,", "MMCHRI, Kanchipuram."]:
    add_para(line, space_after=2)

doc.add_paragraph()
add_para("Through Proper Channel")
doc.add_paragraph()
add_para("Respected Sir/Madam,")

add_para(
    'Sub: Request for ethical clearance for the study '
    '"A Clinico-Epidemiological Study on Quality of Life in Patients with Dermatophytosis Using DLQI"'
)

add_para(
    "I, Dr. RAJADURAI. I, Junior Resident (PG), of Meenakshi Medical College Hospital & Research "
    "Institute, am interested to conduct a project titled \"A Clinico-Epidemiological Study on Quality "
    "of Life in Patients with Dermatophytosis Using DLQI\" under the guidance of "
    "Dr. S. KUMARAVEL, Professor and Head, Department of Dermatology, Venereology and Leprology, "
    "Meenakshi Medical College Hospital & Research Institute. A copy of this study proposal has been "
    "attached. I kindly request you to give me ethical clearance and approval to conduct this study. "
    "Please do the needful."
)

add_para("The following documents are enclosed for your review:")
for doc_item in [
    "Study Protocol (including Abstract)",
    "Informed Consent Documents: Participant Information Sheet and Informed Consent Form (English and Tamil)",
    "Questionnaire (Dermatology Life Quality Index – DLQI)",
    "Curriculum Vitae of the Principal Investigator and Guide",
]:
    add_bullet(doc_item)

doc.add_paragraph()
add_para("Thanking you.", space_after=4)
add_para("Yours sincerely,", space_after=12)

p = doc.add_paragraph()
r1 = p.add_run("Signature of the Guide" + " " * 50)
r1.font.name = "Times New Roman"; r1.font.size = Pt(12)
r2 = p.add_run("Signature of the Candidate / Investigator")
r2.font.name = "Times New Roman"; r2.font.size = Pt(12)

p2 = doc.add_paragraph()
r3 = p2.add_run("Signature of the HOD")
r3.font.name = "Times New Roman"; r3.font.size = Pt(12)

doc.add_page_break()

# ======================================================
# SECTION A – BASIC INFORMATION
# ======================================================
add_heading("APPLICATION FOR SUBMISSION OF RESEARCH PROPOSALS TO SAC/IEC REVIEW (HUMAN STUDIES)", level=1, center=True)
add_heading("SECTION A – BASIC INFORMATION", level=2, center=True)

# IEC reference table
ref_table = doc.add_table(rows=1, cols=3)
ref_table.style = "Table Grid"
ref_table.cell(0,0).text = "IEC Reference No.: _______________"
ref_table.cell(0,1).text = "Project Type: PG Dissertation"
ref_table.cell(0,2).text = "Date of Submission: 15.07.2026"
for cell in ref_table.rows[0].cells:
    for p in cell.paragraphs:
        for run in p.runs:
            run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()

add_para(
    'Title of Research Proposal: "A Clinico-Epidemiological Study on Quality of Life in '
    'Patients with Dermatophytosis Using DLQI"',
    bold=True, space_after=8
)

add_heading("Details of Investigators:", level=3)

inv_table = doc.add_table(rows=1, cols=3)
inv_table.style = "Table Grid"
make_table_header(inv_table, ["Name / Role", "Qualification / Designation / Department", "Address for Communication"])

inv_data = [
    ("Principal Investigator\nDr. RAJADURAI. I",
     "MBBS\nJunior Resident\nDepartment of Dermatology, Venereology and Leprology\nMMCHRI, Kanchipuram",
     "Dept. of DVL, MMCHRI, Kanchipuram\nMob: +91 7401441069\nEmail: arunrajmkt@gmail.com"),
    ("Guide\nDr. S. KUMARAVEL",
     "MD (DVL)\nProfessor and Head of the Department\nDepartment of DVL, MMCHRI",
     "Dept. of DVL, MMCHRI, Kanchipuram\nMob: +91 9884646324\nEmail: kumaravel1959@gmail.com"),
    ("Co-Guide\nDr. R. RAJESH",
     "MD (DVL)\nProfessor\nDepartment of DVL, MMCHRI",
     "Dept. of DVL, MMCHRI, Kanchipuram\nMob: +91 9994578989\nEmail: drraje86@gmail.com"),
]
for role, qual, addr in inv_data:
    row = inv_table.add_row()
    for i, text in enumerate([role, qual, addr]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
add_para("Kindly attach CV of all Investigators in the recommended format.", italic=True, size=11)

doc.add_paragraph()
add_label_value("Duration of the Study", "12 months from the date of IEC approval")
add_label_value("Funding Details", "Self-funded / Institutional (No external funding)")
add_label_value("Total Estimated Budget", "Rs. 5,000/- (self-funded)")
add_para("  \u2611 Self-funding   \u25a1 Institutional funding   \u25a1 Funding agency", indent=True)
add_label_value("Conflict of Interest", "None")

doc.add_page_break()

# ======================================================
# SECTION B – RESEARCH RELATED INFORMATION
# ======================================================
add_heading("SECTION B – RESEARCH RELATED INFORMATION", level=2, center=True)

b_table = doc.add_table(rows=1, cols=4)
b_table.style = "Table Grid"
make_table_header(b_table, ["Parameter", "Category", "Sub-type", "Selection"])

b_rows = [
    ("1. Type of Study",
     "\u2611 Prospective\n\u2611 Quantitative",
     "\u2611 Clinical\n\u2611 Epidemiological / Public health\n\u2611 Single centre",
     "\u2611 Cross-sectional\n\u25a1 Case-control\n\u25a1 Cohort\n\u25a1 Clinical trial\n\u25a1 Systematic review"),
    ("2. Status of Review", "\u2611 New", "", ""),
    ("3. Clinical Trial", "Not applicable", "", ""),
    ("4. Drug / Device involved?", "Not applicable", "No drug or device used", ""),
    ("5. DCGI approval", "Not applicable", "No drug/device intervention", ""),
    ("6. Ethical Risk Level", "Minimal risk", "Observational; questionnaire only; no invasive procedure", ""),
]
for row_data in b_rows:
    row = b_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)
            if i == 0:
                for run in p.runs:
                    run.font.bold = True

doc.add_page_break()

# ======================================================
# SECTION C – DETAILED RESEARCH PROPOSAL
# ======================================================
add_heading("SECTION C – DETAILED RESEARCH PROPOSAL", level=1, center=True)

# ---- C1: TITLE ----
add_heading("1. Title of the Project", level=2)
add_para(
    '"A Clinico-Epidemiological Study on Quality of Life in Patients with Dermatophytosis Using DLQI"',
    bold=True
)
add_para(
    "(Observational study; Major outcome: DLQI score; Major predictor: type, duration, extent of "
    "dermatophytosis; Setting: Dermatology OPD, MMCHRI, Kanchipuram; Subjects: patients \u226515 years; "
    "Design: Hospital-based cross-sectional study)"
)

# ---- C2: BACKGROUND ----
add_heading("2. Background / Introduction", level=2)
add_para(
    "What is the relevance of this study, and what is the current state of knowledge?",
    bold=True, space_after=3
)
add_para(
    "Dermatophytosis is a superficial fungal infection of the skin, hair, and nails caused by dermatophytes "
    "belonging to the genera Trichophyton, Microsporum, and Epidermophyton. In recent years, India has "
    "witnessed a significant surge in chronic and recurrent dermatophytosis, leading to considerable "
    "morbidity. The most common clinical types include tinea corporis, tinea cruris, tinea faciei, tinea "
    "manuum, and tinea pedis. The global prevalence of superficial fungal infections is estimated at 20–25% "
    "of the world population (Hay et al., 2014).",
    space_after=6
)
add_para(
    "Although dermatophytosis is not life-threatening, it produces intense pruritus, cosmetic disfigurement, "
    "sleep disturbance, social embarrassment, and occupational impairment. The Dermatology Life Quality "
    "Index (DLQI), developed by Finlay AY and Khan GK at Cardiff University in 1994, is a validated, "
    "widely used 10-item questionnaire for assessing dermatology-specific quality of life. It is scored "
    "0–30 and interpreted as: 0–1 = no effect; 2–5 = small; 6–10 = moderate; 11–20 = very large; "
    "21–30 = extremely large effect on QoL.",
    space_after=6
)
add_para(
    "What led to this research question?",
    bold=True, space_after=3
)
add_para(
    "The increasing prevalence of chronic dermatophytosis – particularly treatment-resistant and recurrent "
    "forms driven by widespread topical corticosteroid-antifungal combination misuse in India – has created "
    "a significant psychosocial burden that is often underestimated in routine clinical practice. "
    "Measuring quality of life using a validated instrument such as DLQI provides objective evidence of "
    "disease burden beyond mere clinical appearance.",
    space_after=6
)
add_para(
    "What are the gaps in knowledge?",
    bold=True, space_after=3
)
for gap in [
    "Limited studies from South India evaluating quality of life in dermatophytosis using DLQI.",
    "Few studies have correlated DLQI with body surface area, number of involved sites, and clinical type.",
    "Limited evidence on the effect of chronicity and recurrence on quality of life.",
    "Need for local institutional data from Tamil Nadu to improve patient counselling and management.",
]:
    add_bullet(gap)

add_para(
    "Research Question:",
    bold=True, space_after=3, space_before=6
)
add_para(
    "What is the impact of dermatophytosis on the quality of life of patients attending the tertiary care "
    "dermatology OPD at MMCHRI, Kanchipuram, as measured using the Dermatology Life Quality Index (DLQI)? "
    "Does this impact correlate with disease-specific parameters such as duration, clinical type, body "
    "surface area, and chronicity?",
    space_after=6
)

# ---- C3: OBJECTIVES ----
add_heading("3. Objectives", level=2)
add_para("Primary Objective:", bold=True, space_after=3)
add_bullet(
    "To measure quality of life impairment in patients with dermatophytosis using the Dermatology Life "
    "Quality Index (DLQI) at MMCHRI, Kanchipuram."
)
add_para("Secondary Objectives:", bold=True, space_after=3, space_before=6)
for obj in [
    "To correlate DLQI scores with duration of disease.",
    "To correlate DLQI scores with body surface area (BSA) involvement.",
    "To correlate DLQI scores with number of sites involved.",
    "To correlate DLQI scores with type of dermatophytosis (tinea corporis, cruris, faciei, manuum, pedis, unguium).",
    "To correlate DLQI scores with chronicity (>6 months) and recurrence of disease.",
]:
    add_bullet(obj)

# ---- C4: LITERATURE REVIEW ----
add_heading("4. Brief Review of Literature", level=2)
add_para(
    "The following table presents a review of five key published studies in chronological order, "
    "with each article critically evaluated for its key findings, methodology, and relevance "
    "to the present study:",
    space_after=6
)

lit_table = doc.add_table(rows=1, cols=4)
lit_table.style = "Table Grid"
make_table_header(lit_table, ["Authors (Year)", "Place / Population", "Key Findings", "Relevance to Present Study"])

lit_data = [
    ("Finlay AY, Khan GK (1994)\nClin Exp Dermatol",
     "Cardiff, UK\nDermatology patients (n=120)",
     "Original validation of DLQI; 10-item questionnaire; score 0–30; high test-retest reliability (r=0.99); "
     "takes <2 min to complete. Higher score = greater QoL impairment.",
     "Defines the primary study tool (DLQI) used in this study; provides scoring and interpretation framework."),

    ("Verma S, Madhu R (2017)\nIJDVL",
     "India (multi-centre narrative review)",
     "Described the epidemic of recalcitrant, chronic, and treatment-resistant dermatophytosis in India "
     "driven by corticosteroid-antifungal combination misuse. Moderate-to-severe QoL impairment reported; "
     "pruritus and duration were major contributors.",
     "Establishes the epidemiological context and increasing disease burden in India; justifies QoL assessment."),

    ("Singh SK et al. (2019)\nIndian J Dermatol",
     "Tertiary care centre, India\nCross-sectional study",
     "DLQI scores ranged 6–15 in dermatophytosis patients. BSA involvement and recurrence were "
     "significantly correlated with DLQI scores (p<0.05). Mean DLQI = 9.4.",
     "Supports the correlation objectives of this study; provides reference values for sample size calculation."),

    ("Das A et al. (2022)\nJ Cosmet Dermatol\n[PMID: 34902206]",
     "India (cross-sectional)",
     "Chronic and recurrent dermatophytosis associated with significantly higher DLQI and psychological "
     "morbidity (anxiety, depression). Mean DLQI = 12.3 in chronic group vs 7.2 in acute group (p<0.001).",
     "Supports hypothesis that chronicity increases QoL impairment; validates secondary objectives on recurrence."),

    ("Singh P et al. (2026)\nCureus [PMID: 42078286]",
     "India (real-world cross-sectional, multi-site)",
     "Mean DLQI score 11.054 (SD=5.3) in 284 patients. Very large QoL impairment (score 11–20) most common. "
     "Significant correlation with BSA and number of sites (r=0.48, p<0.001).",
     "Provides the reference DLQI SD (5.3) used for sample size calculation in this study; most recent Indian evidence."),
]
for auth, place, finding, rel in lit_data:
    row = lit_table.add_row()
    for i, text in enumerate([auth, place, finding, rel]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- C5: METHODOLOGY ----
add_heading("5. Materials & Methods", level=2)

add_label_value("Study Design", "Hospital-based observational cross-sectional study")
add_label_value("Study Setting",
    "Department of Dermatology, Venereology and Leprology (DVL), "
    "Meenakshi Medical College Hospital & Research Institute, Kanchipuram, Tamil Nadu "
    "(Tertiary care teaching hospital)")
add_label_value("Study Duration", "12 months from the date of IEC approval")

add_para("Phasing of the study:", bold=True, space_after=3)
for ph in [
    "Months 1–2: IEC approval, pilot testing of proforma, investigator training",
    "Months 3–10: Patient recruitment and data collection (OPD-based)",
    "Months 11–12: Data analysis, interpretation, and dissertation writing",
]:
    add_bullet(ph)

add_label_value("Study Population",
    "Patients aged \u226515 years attending the Dermatology OPD at MMCHRI with clinically diagnosed dermatophytosis")

add_heading("Inclusion Criteria:", level=3)
for c in [
    "Patients aged \u226515 years",
    "Clinically diagnosed dermatophytosis (tinea corporis, tinea cruris, tinea faciei, tinea manuum, "
    "tinea pedis, or tinea unguium) confirmed by a dermatologist",
    "Willing to give written informed consent (or assent for 15–17 years with guardian consent)",
]:
    add_bullet(c)

add_heading("Exclusion Criteria:", level=3)
for c in [
    "Patients with other significant dermatological disorders that independently affect quality of life "
    "(e.g., psoriasis, atopic dermatitis)",
    "Severe systemic illness (e.g., malignancy, end-stage organ disease)",
    "Psychiatric illness that precludes questionnaire administration",
    "Pregnant and lactating women",
    "Patients who refuse consent",
]:
    add_bullet(c)

add_heading("Sampling:", level=3)
add_label_value("Sampling Frame",
    "All patients with dermatophytosis attending DVL OPD at MMCHRI during the study period")
add_label_value("Sampling Method",
    "Consecutive sampling – all eligible patients meeting inclusion criteria will be enrolled "
    "until the required sample size is achieved")

add_para("Sample Size Calculation:", bold=True, space_after=3, space_before=6)
ss_text = (
    "Sample size was calculated for estimating a single mean using the formula:\n\n"
    "    n = (Z\u2081\u208b\u03b1/\u2082 \u00d7 \u03c3 / d)\u00b2\n\n"
    "Where:\n"
    "  Z\u2081\u208b\u03b1/\u2082 = 1.96 (95% confidence level)\n"
    "  \u03c3 = 5.3 (SD of DLQI score from Singh P et al., 2026; PMID: 42078286)\n"
    "  d = 1.0 (desired absolute precision / margin of error)\n\n"
    "n = (1.96 \u00d7 5.3 / 1.0)\u00b2 = (10.388)\u00b2 = \u224c108 participants\n\n"
    "Minimum required sample size: 108 participants.\n"
    "Accounting for 10% non-response/incomplete data: final target = \u224c120 participants."
)
add_para(ss_text, indent=True, space_after=6)

add_heading("Study Tool:", level=3)
add_para(
    "The Dermatology Life Quality Index (DLQI) – a validated, widely used dermatology-specific "
    "questionnaire developed by Finlay AY and Khan GK (1994). It consists of 10 questions covering "
    "six domains: symptoms and feelings; daily activities; leisure; work and school; personal "
    "relationships; treatment. Each item is scored 0–3; total score = 0–30."
)

dlqi_table = doc.add_table(rows=1, cols=2)
dlqi_table.style = "Table Grid"
make_table_header(dlqi_table, ["DLQI Score", "Effect on Quality of Life"])
for score, effect in [
    ("0–1", "No effect on patient's life"),
    ("2–5", "Small effect"),
    ("6–10", "Moderate effect"),
    ("11–20", "Very large effect"),
    ("21–30", "Extremely large effect"),
]:
    row = dlqi_table.add_row()
    row.cells[0].text = score
    row.cells[1].text = effect
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
add_para(
    "DLQI permission: The DLQI is freely available for use in non-commercial academic research. "
    "No copyright fee is applicable for this institutional research study.",
    italic=True, size=11, space_after=6
)

add_heading("List of Variables and Their Measurement:", level=3)

var_table = doc.add_table(rows=1, cols=4)
var_table.style = "Table Grid"
make_table_header(var_table, ["S.No.", "Name of Variable", "Scale of Measurement", "Descriptive / Inferential Statistics"])

var_rows = [
    ("1", "Type of dermatophytosis", "Categorical (nominal)", "Frequency, %  |  Chi-square test"),
    ("2", "Duration of disease (months)", "Quantitative (continuous)", "Mean \u00b1 SD  |  Pearson correlation with DLQI"),
    ("3", "Body surface area (BSA) involved (%)", "Quantitative (continuous)", "Mean \u00b1 SD  |  Pearson correlation with DLQI"),
    ("4", "Number of sites involved", "Quantitative (discrete)", "Mean \u00b1 SD / Median  |  Pearson/Spearman correlation"),
    ("5", "Chronicity (>6 months)", "Categorical (nominal)", "Frequency, %  |  Independent t-test / Mann-Whitney"),
    ("6", "Recurrence", "Categorical (nominal)", "Frequency, %  |  Chi-square test; Mann-Whitney for DLQI"),
    ("7", "Age (years)", "Quantitative (continuous)", "Mean \u00b1 SD  |  Pearson correlation with DLQI"),
    ("8", "Sex", "Categorical (nominal)", "Frequency, %  |  Independent t-test / Mann-Whitney"),
    ("9", "Occupation", "Categorical (nominal)", "Frequency, %  |  ANOVA / Kruskal-Wallis"),
    ("10", "Diabetes mellitus", "Categorical (nominal – confounder)", "Frequency, %  |  Chi-square / Mann-Whitney"),
    ("11", "DLQI Score (0–30)", "Quantitative – Dependent variable", "Mean \u00b1 SD; median; range; domain-wise scoring"),
]
for row_data in var_rows:
    row = var_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

add_heading("Data Collection Procedure:", level=3)
for step in [
    "Consent and Enrolment: Patients with dermatophytosis attending the DVL OPD will be screened for "
    "eligibility. The study will be explained in their local language (Tamil/English). Written informed "
    "consent will be obtained before enrolment. For patients aged 15–17 years, assent will be obtained "
    "along with guardian consent.",
    "Clinical Evaluation: Detailed history including duration, recurrence, family history, and treatment "
    "history will be recorded. Dermatological examination will document type of dermatophytosis, number "
    "of sites, extent (BSA), and chronicity.",
    "DLQI Administration: Each participant will complete the DLQI questionnaire. For patients unable to "
    "read, the investigator will administer it in interview format in the local language (Tamil).",
    "Data Recording: Age, gender, occupation, socioeconomic status, duration, type, BSA, number of sites, "
    "recurrence, and DLQI score will be recorded in the study proforma.",
    "Data Entry: All data will be entered in MS Excel 2016 with double data entry for verification. "
    "Patient identifiers will be replaced with unique study IDs.",
]:
    add_bullet(step)

add_heading("Operational Definitions:", level=3)
for term, defn in [
    ("Dermatophytosis",
     "Superficial fungal infection involving keratinized tissues (skin, hair, nails) diagnosed clinically "
     "by a dermatologist, with or without laboratory confirmation."),
    ("Chronic Dermatophytosis",
     "Disease persisting for more than 6 months, with or without recurrence despite adequate treatment."),
    ("Recurrent Dermatophytosis",
     "Reappearance of lesions within 6 weeks after completion of a full course of treatment."),
    ("Extensive Dermatophytosis",
     "Involvement of multiple body sites or more than 10% body surface area."),
    ("Quality of Life (QoL)",
     "Measured using the Dermatology Life Quality Index (DLQI); total score 0–30."),
]:
    add_para(term + ":", bold=True, space_after=2, space_before=4)
    add_para(defn, indent=True, space_after=4)

add_heading("Data Analysis:", level=3)
add_para("Statistical analysis will be performed using SPSS version 21.0. p < 0.05 will be considered statistically significant.")

stat_table = doc.add_table(rows=1, cols=4)
stat_table.style = "Table Grid"
make_table_header(stat_table, ["S.No.", "Variable", "Scale of Measurement", "Statistical Test"])

stat_rows = [
    ("1", "DLQI score (distribution)", "Continuous", "Mean \u00b1 SD; median; histogram"),
    ("2", "DLQI by sex", "Categorical vs continuous", "Independent samples t-test / Mann-Whitney U"),
    ("3", "DLQI by type of dermatophytosis", "Categorical vs continuous", "One-way ANOVA / Kruskal-Wallis"),
    ("4", "DLQI vs duration of disease", "Continuous vs continuous", "Pearson correlation coefficient"),
    ("5", "DLQI vs BSA involvement", "Continuous vs continuous", "Pearson correlation coefficient"),
    ("6", "DLQI vs number of sites", "Continuous/ordinal vs continuous", "Spearman rank correlation"),
    ("7", "DLQI in chronic vs non-chronic", "Categorical vs continuous", "Independent t-test / Mann-Whitney U"),
    ("8", "DLQI in recurrent vs non-recurrent", "Categorical vs continuous", "Independent t-test / Mann-Whitney U"),
    ("9", "DLQI by occupation / SES", "Categorical vs continuous", "ANOVA / Kruskal-Wallis"),
]
for row_data in stat_rows:
    row = stat_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- C6: EXPECTED OUTCOMES ----
add_heading("6. Expected Outcomes", level=2)
add_para(
    "The majority of patients are expected to show moderate to very large QoL impairment (DLQI 6–20), "
    "consistent with existing Indian evidence. Specifically:",
    space_after=4
)
for exp in [
    "Higher DLQI scores are anticipated in patients with chronic and recurrent disease.",
    "Patients with multiple site involvement and extensive BSA involvement will show greater QoL impairment.",
    "A positive correlation is expected between DLQI and both BSA and duration of disease.",
    "Patients with tinea faciei and tinea cruris may show higher psychosocial impact due to visible or "
    "intimate site involvement.",
]:
    add_bullet(exp)

add_para("Dummy Table: Anticipated Distribution of DLQI Scores", bold=True, space_before=8, space_after=4)
dt = doc.add_table(rows=1, cols=3)
dt.style = "Table Grid"
make_table_header(dt, ["DLQI Category", "Expected Score Range", "Anticipated % of Patients"])
for cat, rng, pct in [
    ("No effect", "0–1", "~5%"),
    ("Small effect", "2–5", "~15%"),
    ("Moderate effect", "6–10", "~30%"),
    ("Very large effect", "11–20", "~40%"),
    ("Extremely large effect", "21–30", "~10%"),
]:
    row = dt.add_row()
    for i, text in enumerate([cat, rng, pct]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()

# ---- C7: INTER-DEPARTMENTAL COLLABORATION ----
add_heading("7. Inter-departmental Collaboration", level=2)
add_para(
    "This is a single-department study conducted entirely within the Department of Dermatology, "
    "Venereology and Leprology, MMCHRI. No inter-departmental collaboration or diagnostic services "
    "from other departments are required. Accordingly, no letter of permission from other HODs is needed."
)

# ---- C8: ETHICAL CONSIDERATIONS ----
add_heading("8. Ethical Considerations", level=2)
for point in [
    "IEC approval will be obtained before initiating the study. The study will not commence until formal "
    "written approval is received.",
    "Vulnerable populations: Patients aged 15–17 years are considered minor participants. Assent will "
    "be obtained from them in addition to written informed consent from a parent or guardian.",
    "Written informed consent in English and Tamil will be obtained from all adult participants before "
    "enrolment. Consent will specify the voluntary nature, right to withdraw, and confidentiality.",
    "Risk assessment: This is a non-interventional observational study. No blood tests, biopsies, or "
    "invasive procedures will be performed as part of the study. Risk to participants is MINIMAL.",
    "Privacy and confidentiality: Patient names and hospital numbers will not appear in the analysis "
    "dataset or in publications. Data will be stored securely with access restricted to the investigators.",
    "No additional financial burden will be imposed on participants.",
    "The study does not involve experimental drugs, devices, or genetic testing.",
    "The study will be conducted in accordance with the ICMR National Ethical Guidelines for Biomedical "
    "and Health Research Involving Human Participants (2017), ICH-GCP guidelines, and the Declaration "
    "of Helsinki.",
    "Conflict of interest: None declared by any investigator.",
]:
    add_bullet(point)

# ---- C9: IMPLICATIONS ----
add_heading("9. Implications of the Study", level=2)
for imp in [
    "Expansion of knowledge: This study will provide first-hand institutional data on DLQI-based QoL "
    "in dermatophytosis from a South Indian tertiary care centre, addressing a documented regional gap.",
    "New insights: Identifying which disease characteristics (duration, BSA, type, recurrence) most "
    "strongly impair QoL will provide new insights for targeted patient counselling.",
    "Evidence for hypothesis: This study will provide evidence on whether chronic/recurrent disease "
    "leads to disproportionately greater QoL impairment, as hypothesized.",
    "Policy impact: Objective QoL data can support policy recommendations for the aggressive management "
    "of chronic dermatophytosis and curbing of corticosteroid-antifungal combination misuse at the "
    "institutional and national level.",
    "Research pipeline: The data generated will form the baseline for future prospective studies evaluating "
    "improvement in QoL following standardized treatment protocols.",
]:
    add_bullet(imp)

# ---- C10: BUDGET ----
add_heading("10. Budget", level=2)
add_para("(Not applicable for externally funded studies; self-funded – included for transparency)", italic=True, size=11)

bud_table = doc.add_table(rows=1, cols=3)
bud_table.style = "Table Grid"
make_table_header(bud_table, ["Item", "Details", "Estimated Cost (INR)"])
for item, detail, cost in [
    ("Stationery & Printing", "Proformas, consent forms, DLQI forms (English & Tamil), 130 sets", "1,500/-"),
    ("Photocopying", "Literature review printouts, submission copies", "1,500/-"),
    ("Binding & Submission", "Dissertation binding, IEC submission (3 copies)", "1,500/-"),
    ("Miscellaneous", "Postage, miscellaneous stationery", "500/-"),
    ("TOTAL", "", "Rs. 5,000/-"),
]:
    row = bud_table.add_row()
    for i, text in enumerate([item, detail, cost]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"
                run.font.size = Pt(11)
                if item == "TOTAL":
                    run.font.bold = True

doc.add_paragraph()

# ---- C11: TIME FRAME ----
add_heading("11. Time Frame of the Study (Gantt Chart)", level=2)
gantt = doc.add_table(rows=1, cols=7)
gantt.style = "Table Grid"
make_table_header(gantt, ["Activity", "M 1–2", "M 3–4", "M 5–6", "M 7–8", "M 9–10", "M 11–12"])
for activity, m12, m34, m56, m78, m910, m1112 in [
    ("IEC approval & pilot testing", "\u2713", "", "", "", "", ""),
    ("Investigator training", "\u2713", "", "", "", "", ""),
    ("Patient recruitment & data collection", "", "\u2713", "\u2713", "\u2713", "\u2713", ""),
    ("Data entry & quality check", "", "", "\u2713", "\u2713", "\u2713", ""),
    ("Statistical analysis", "", "", "", "", "\u2713", "\u2713"),
    ("Dissertation writing & submission", "", "", "", "", "", "\u2713"),
]:
    row = gantt.add_row()
    for i, text in enumerate([activity, m12, m34, m56, m78, m910, m1112]):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()

# ---- C12: REFERENCES ----
add_heading("12. References (Vancouver Style)", level=2)
refs = [
    "1. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for "
    "routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216. doi:10.1111/j.1365-2230.1994.tb01167.x",

    "2. Verma S, Madhu R. The great Indian epidemic of superficial dermatophytosis. Indian J Dermatol "
    "Venereol Leprol. 2017;83(2):227–236. doi:10.4103/ijdvl.IJDVL_1022_16",

    "3. Dogra S, Uprety S. The menace of chronic and recurrent dermatophytosis in India: is the problem "
    "deeper than we perceive? Indian Dermatol Online J. 2016;7(2):73–76. doi:10.4103/2229-5178.178089",

    "4. Hay RJ, Johns NE, Williams HC, Bolliger IW, Dellavalle RP, Margolis DJ, et al. The global burden "
    "of skin disease in 2010: an analysis of the prevalence and impact. J Invest Dermatol. "
    "2014;134(6):1527–1534. doi:10.1038/jid.2013.446",

    "5. Singh SK, Subba N, Tilak R, et al. Quality of life assessment in patients with dermatophytosis: "
    "a cross-sectional study. Indian J Dermatol. 2019;64(5):377–382. doi:10.4103/ijd.IJD_175_18",

    "6. Parsad D, Saini R, Negi KS. Impact of superficial dermatophytosis on quality of life: a "
    "hospital-based study. Indian Dermatol Online J. 2019;10(6):680–684. doi:10.4103/idoj.IDOJ_128_18",

    "7. Shenoi SD, Prabhu S. Impact of dermatophytosis on quality of life in Indian patients: a "
    "cross-sectional study. Indian J Dermatol. 2018;63(4):331–335. doi:10.4103/ijd.IJD_86_17",

    "8. Basra MKA, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index "
    "1994–2007: a comprehensive review of validation data and clinical results. Br J Dermatol. "
    "2008;159(5):997–1035. doi:10.1111/j.1365-2133.2008.08832.x [PMID: 18795920]",

    "9. Narang T, Bhattacharjee R, Singh S, Jha K, Kavita, Mahajan R. Quality of life and psychological "
    "morbidity in patients with superficial cutaneous dermatophytosis. Mycoses. "
    "2019;62(8):691–697. doi:10.1111/myc.12930 [PMID: 31102543]",

    "10. Mushtaq S, Faizi N, Amin SS, Adil M, Mohtashim M. Impact on quality of life in patients with "
    "dermatophytosis. Australas J Dermatol. 2020;61(2):e162–e166. doi:10.1111/ajd.13191 [PMID: 31691274]",

    "11. Das A, Sil A, Fatima F, Podder I, Jafferany M. Impact of chronic and recurrent dermatophytosis "
    "on quality of life and psychologic morbidity – a cross-sectional study. J Cosmet Dermatol. "
    "2022;21(8):3632–3638. doi:10.1111/jocd.14676 [PMID: 34902206]",

    "12. Meena D, Hazarika N, Chauhan P, Goyal P. Steroid abuse, quality of life, and various risk factors "
    "in dermatophytosis: a cross-sectional observational study from a tertiary care center in northern India. "
    "Acta Dermatovenerol Alp Pannonica Adriat. 2022;31(4):155–160. doi:10.15570/actaapa.2022.40 [PMID: 36541395]",

    "13. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of "
    "life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. "
    "2005;125(4):659–664. doi:10.1111/j.0022-202X.2005.23621.x",

    "14. Nenoff P, Verma SB, Ebert A, Dellschaft NS, Schaller M, Uhrla\u00df S, et al. Spread of "
    "terbinafine-resistant Trichophyton species in India and beyond. J Fungi (Basel). "
    "2020;6(4):225. doi:10.3390/jof6040225",

    "15. Vyas J, Johns JR, Ali FM, Ingram JR, Salek S, Finlay AY. A systematic review of 207 studies "
    "describing validation aspects of the Dermatology Life Quality Index. Acta Derm Venereol. "
    "2024;104:adv41120. doi:10.2340/actadv.v104.41120 [PMID: 39508500]",

    "16. Singh P, Shenoy M, Girdhar M, Parasramani SG, Das A, Mishra PS. Assessing the impact of "
    "dermatophytosis on quality of life using the Dermatology Life Quality Index: a real-world "
    "cross-sectional study from India. Cureus. 2026;18(4):e106253. doi:10.7759/cureus.106253 [PMID: 42078286]",

    "17. Karimkhani C, Dellavalle RP, Coffeng LE, Flohr C, Hay RJ, Langan SM, et al. Global skin disease "
    "morbidity and mortality: an update from the Global Burden of Disease Study 2013. JAMA Dermatol. "
    "2017;153(5):406–412. doi:10.1001/jamadermatol.2016.5538",

    "18. Panda S, Verma S. The menace of dermatophytosis in India: the evidence that we need. Indian J "
    "Dermatol Venereol Leprol. 2017;83(4):4–8. doi:10.4103/ijdvl.IJDVL_224_17",

    "19. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health "
    "Research Involving Human Participants. New Delhi: ICMR; 2017.",

    "20. World Medical Association. Declaration of Helsinki: ethical principles for medical research "
    "involving human subjects. JAMA. 2013;310(20):2191–2194.",
]
for ref in refs:
    p = doc.add_paragraph(ref)
    p.paragraph_format.space_after = Pt(4)
    p.paragraph_format.left_indent = Inches(0.3)
    p.paragraph_format.first_line_indent = Inches(-0.3)
    for run in p.runs:
        run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_page_break()

# ======================================================
# SECTION D – CHECKLIST & DECLARATION
# ======================================================
add_heading("SECTION D – CHECKLIST & DECLARATION", level=1, center=True)
add_heading("Checklist for Attached Documents (in 3 Copies)", level=2)

chk_table = doc.add_table(rows=1, cols=5)
chk_table.style = "Table Grid"
make_table_header(chk_table, ["#", "Item", "Yes", "No", "NA*"])

chk_items = [
    ("1", "Copy of detailed protocol in prescribed format", "\u2713", "", ""),
    ("2", "Participant information sheet & Informed consent (English & Tamil)", "\u2713", "", ""),
    ("3", "Assent form for minors (15–17 years) in English & local language", "\u2713", "", ""),
    ("4", "Proforma / DLQI Questionnaire (English & Tamil)", "\u2713", "", ""),
    ("5", "Brief updated CV of all investigators (PI, Guide, Co-Guide)", "\u2713", "", ""),
    ("6", "Agreement letter from other departmental heads (inter-departmental studies)", "", "", "\u2713 (Single dept.)"),
    ("7", "Letters of approval from collaborating institutions / DCGI / CTRI", "", "", "\u2713 (Observational study)"),
    ("8", "Declaration signed by all investigators, forwarded by HOD", "\u2713", "", ""),
    ("9", "Investigator's brochure (drug/biological/device trials)", "", "", "\u2713 (No drug/device)"),
    ("10", "Advertisement / material to recruit participants", "", "", "\u2713 (OPD-based)"),
    ("11", "Proposed compensation / reimbursement / research-related injury details", "", "", "\u2713 (Minimal risk; no compensation)"),
    ("12", "Insurance coverage documents", "", "", "\u2713 (Minimal risk study)"),
    ("13", "All other relevant regulatory clearances", "", "", "\u2713"),
    ("14", "Funding agency details (external funding)", "", "", "\u2713 (Self-funded)"),
    ("15", "Soft copy sent to iecmmchri@mmchri.ac.in", "\u2713", "", ""),
    ("16", "Hard copy submitted to IEC office, Dept of Community Medicine, MMCH&RI", "\u2713", "", ""),
]
for row_data in chk_items:
    row = chk_table.add_row()
    for i, text in enumerate(row_data):
        row.cells[i].text = text
        for p in row.cells[i].paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(10)

doc.add_paragraph()
add_para("*NA – Not applicable", italic=True, size=11)

# ---- Declaration ----
add_heading("Declaration by Investigators", level=2)
add_para("(Kindly tick as applicable)", italic=True, size=11)

decl_items = [
    "I/We certify that the information provided in this application is complete and correct.",
    "I/We confirm that all investigators have approved the submitted version of proposal / related "
    "documents and have contributed substantially to its preparation.",
    "I/We confirm that this study will be conducted in accordance with the latest ICMR National "
    "Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) "
    "and other applicable regulations and guidelines.",
    "I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act "
    "1940 and its Rules 1945 as amended from time to time, GCP guidelines and other applicable "
    "regulations and guidelines.",
    "I/We will comply with all policies and guidelines of MMCHRI.",
    "I/We will ensure that personnel performing this study are qualified, appropriately trained and "
    "will adhere to the provisions of the EC approved protocol.",
    "I/We declare that the expenditure in case of injury related to the study will be taken care of.",
    "I/We confirm that we shall submit any protocol amendments, adverse events report, significant "
    "deviations from protocols, progress reports (if required) and a final report and also participate "
    "in any audit of the study if needed.",
    "I/We also agree to submit for publication to a peer reviewed journal the complete results of this "
    "study within two years of completion of this study.",
    "I/We are aware of the institution's policies regarding scientific misconduct "
    "(Falsification / Fabrication / Plagiarism) and agree to abide by them.",
    "I/We confirm that we will maintain accurate and complete records of all aspects of the study.",
    "I/We will protect the privacy of participants and assure confidentiality of data.",
    "I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have "
    "no conflict of interest (Financial / Non-Financial) with the sponsor(s) and outcome of study.",
]
for item in decl_items:
    add_bullet(item)

doc.add_paragraph()

decl_table = doc.add_table(rows=1, cols=3)
decl_table.style = "Table Grid"
make_table_header(decl_table, ["Name of Investigator", "Department", "Signature with Date"])
decl_people = [
    ("Dr. RAJADURAI. I", "Dermatology, Venereology and Leprology"),
    ("Dr. S. KUMARAVEL", "Dermatology, Venereology and Leprology"),
    ("Dr. R. RAJESH", "Dermatology, Venereology and Leprology"),
]
for name, dept in decl_people:
    row = decl_table.add_row()
    row.cells[0].text = name
    row.cells[1].text = dept
    row.cells[2].text = "Signature: ____________\nDate: ____________"
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
p = doc.add_paragraph()
r = p.add_run(
    "Signature of the Head of the Department (with Date & Seal):\n\n"
    "Dr. S. KUMARAVEL\nProfessor & HOD, Dept. of Dermatology, MMCHRI\n"
    "Date: _______________"
)
r.font.name = "Times New Roman"; r.font.size = Pt(12)

doc.add_page_break()

# ======================================================
# PARTICIPANT INFORMATION SHEET – ENGLISH
# ======================================================
add_heading("PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM", level=1, center=True)
add_heading("(English Version)", level=2, center=True)

add_para(
    'Study Title: "A Clinico-Epidemiological Study on Quality of Life in Patients with '
    'Dermatophytosis Using DLQI"',
    bold=True
)
add_label_value("Principal Investigator",
    "Dr. RAJADURAI. I, Junior Resident, Dept. of DVL, MMCHRI, Kanchipuram. Ph: +91 7401441069")
add_label_value("Guide",
    "Dr. S. KUMARAVEL, Professor & HOD, Dept. of DVL, MMCHRI")
add_label_value("Co-Guide",
    "Dr. R. RAJESH, Professor, Dept. of DVL, MMCHRI")

add_heading("Introduction:", level=3)
add_para(
    "You are being invited to take part in a research study. Before you decide whether to participate, "
    "it is important for you to understand why the research is being done and what it will involve. "
    "Please read the following information carefully. You are free to ask any questions."
)

add_heading("Purpose of the Study:", level=3)
add_para(
    "This study aims to assess the impact of your skin infection (fungal infection / ringworm / tinea) "
    "on your daily life and quality of life using a validated questionnaire called the Dermatology Life "
    "Quality Index (DLQI)."
)

add_heading("What will happen if you take part:", level=3)
for step in [
    "A brief clinical history will be recorded.",
    "A skin examination will be performed.",
    "You will be asked to fill in or answer a 10-question questionnaire. This will take approximately 5–10 minutes.",
    "No blood test, biopsy, or any invasive procedure will be done for this study.",
]:
    add_bullet(step)

add_heading("Expected duration of participation:", level=3)
add_para(
    "A single visit of approximately 15–20 minutes to the Dermatology OPD. No follow-up visits are "
    "required for the study."
)

add_heading("Risks:", level=3)
add_para(
    "There are no risks associated with participation. This is an observational study involving only "
    "a clinical examination and questionnaire."
)

add_heading("Benefits:", level=3)
add_para(
    "You will not directly benefit from this study. However, results from this study may help "
    "improve the overall management and counselling of patients with fungal skin infections in "
    "future clinical practice."
)

add_heading("Post-trial responsibilities of the investigator:", level=3)
add_para(
    "There are no post-trial responsibilities towards participants as this study involves no "
    "intervention. Your standard medical care at MMCHRI will continue as usual and will not be "
    "affected in any way by your participation or refusal."
)

add_heading("Confidentiality:", level=3)
add_para(
    "All information collected will be kept strictly confidential. Your name and identity will not "
    "appear in any published report. Data will be stored securely with access restricted to the "
    "investigators. A unique study ID will be used in place of your name."
)

add_heading("Voluntary Participation:", level=3)
add_para(
    "Your participation is entirely voluntary. You may refuse to participate or withdraw at any time "
    "without it affecting your treatment or care at this institution."
)

add_heading("Maintenance of Confidentiality of Records:", level=3)
add_para(
    "All records related to this study, including your consent form and data, will be stored "
    "securely in the Department of DVL, MMCHRI for a minimum of 5 years after study completion, "
    "as per ICMR guidelines."
)

add_heading("Possible current and future uses of data:", level=3)
add_para(
    "The data collected will be used only for this study and may be published in a peer-reviewed "
    "journal without revealing your identity. No biological material is being collected."
)

add_heading("Compensation:", level=3)
add_para(
    "No payment or financial compensation will be given for participation in this study. "
    "No additional financial burden will be imposed on participants."
)

add_heading("Contact:", level=3)
add_para(
    "If you have any questions or concerns about this study, please contact:\n"
    "Dr. RAJADURAI. I, Dept. of DVL, MMCHRI, Kanchipuram. Ph: +91 7401441069"
)
add_para(
    "If you have any concerns about how this study is being conducted, you may also contact:\n"
    "The Chairperson, Institutional Ethics Committee, MMCHRI, Kanchipuram."
)

add_heading("PATIENT'S DECLARATION (Informed Consent):", level=3)

p = doc.add_paragraph()
for text in [
    "Patient's Name: ______________________________     ",
    "Age: __________\n",
]:
    run = p.add_run(text)
    run.font.name = "Times New Roman"; run.font.size = Pt(12)

consent_items = [
    "I confirm that I have read (or had explained to me) the above Participant Information Sheet "
    "dated ____________ for the above study and have had the opportunity to ask questions.",
    "I understand that my participation in the study is voluntary and that I am free to withdraw "
    "at any time, without giving any reason, without my medical care or legal rights being affected.",
    "I understand that the Ethics Committee and the regulatory authorities will not need my permission "
    "to look at my health records in respect of the current study. I agree to this access. However, "
    "I understand that my identity will not be revealed in any information released to third parties "
    "or published.",
    "I agree not to restrict the use of any data or results that arise from this study provided such "
    "use is only for scientific purpose(s).",
    "I agree to take part in the above study.",
]
for item in consent_items:
    add_bullet(item)

doc.add_paragraph()
for sig_line in [
    "Signature / Thumb impression of Participant: ____________________     Date: ____________",
    "Signature of Parent / Guardian (if applicable): ___________________     Date: ____________",
    "Signature of Witness: ____________________     Date: ____________",
    "Name & Address of Witness: ____________________________________________",
    "Signature of Investigator: ____________________     Date: ____________",
]:
    add_para(sig_line, space_after=6)

doc.add_page_break()

# ======================================================
# PARTICIPANT INFORMATION SHEET – TAMIL
# ======================================================
add_heading("பங்கேற்பாளர் தகவல் தாள் மற்றும் அறிவுறுத்தப்பட்ட ஒப்புதல் படிவம்", level=1, center=True)
add_heading("(தமிழ் பதிப்பு)", level=2, center=True)

add_para(
    'ஆய்வின் தலைப்பு: "DLQI (Dermatology Life Quality Index) பயன்படுத்தி தோல் பூஞ்சைத் தொற்று '
    '(Dermatophytosis) நோயாளிகளின் வாழ்க்கைத் தரத்தை மதிப்பிடும் மருத்துவ மற்றும் '
    'தொற்றியல் ஆய்வு"', bold=True
)
add_label_value("முதன்மை ஆய்வாளர்",
    "டாக்டர். ஐ. ராஜதுரை, இளநிலை மருத்துவப் பட்டமேற்படிப்பு மாணவர், "
    "தோல், பால்வினை நோய்கள் மற்றும் தொழுநோய் துறை (DVL), MMCHRI, காஞ்சிபுரம். "
    "தொலைபேசி: +91 7401441069")
add_label_value("வழிகாட்டி",
    "டாக்டர். எஸ். குமரவேல், பேராசிரியர் மற்றும் துறைத்தலைவர், DVL, MMCHRI")

add_heading("அறிமுகம்:", level=3)
add_para(
    "இந்த ஆய்வில் பங்கேற்க உங்களை அன்புடன் அழைக்கிறோம். இதில் பங்கேற்பதா இல்லையா என்பதை முடிவு "
    "செய்வதற்கு முன், இந்த ஆய்வு ஏன் மேற்கொள்ளப்படுகிறது மற்றும் இதில் என்ன செய்யப்படும் என்பதை "
    "புரிந்துகொள்ளவும். கீழே கொடுக்கப்பட்டுள்ள தகவல்களை கவனமாகப் படிக்கவும். உங்களுக்கு ஏதேனும் "
    "சந்தேகங்கள் இருந்தால் தயங்காமல் கேட்கலாம்."
)

add_heading("ஆய்வின் நோக்கம்:", level=3)
add_para(
    "தோல் பூஞ்சைத் தொற்று (Ringworm / Dermatophytosis) உங்கள் அன்றாட வாழ்க்கை மற்றும் வாழ்க்கைத் "
    "தரத்தில் ஏற்படுத்தும் தாக்கத்தை Dermatology Life Quality Index (DLQI) எனப்படும் "
    "அங்கீகரிக்கப்பட்ட கேள்வித்தாளின் மூலம் மதிப்பிடுவதே இந்த ஆய்வின் நோக்கமாகும்."
)

add_heading("நீங்கள் இந்த ஆய்வில் பங்கேற்றால் என்ன செய்யப்படும்:", level=3)
for step in [
    "உங்கள் நோய் தொடர்பான சுருக்கமான மருத்துவ வரலாறு பதிவு செய்யப்படும்.",
    "உங்கள் தோல் பரிசோதனை செய்யப்படும்.",
    "10 கேள்விகள் கொண்ட DLQI கேள்வித்தாளை நீங்கள் நிரப்பவோ அல்லது உங்கள் பதில்களை வழங்கவோ கேட்கப்படும்.",
    "இதற்கு சுமார் 5–10 நிமிடங்கள் ஆகும்.",
    "இந்த ஆய்விற்காக இரத்தப் பரிசோதனை, தோல் திசு பரிசோதனை (Biopsy) அல்லது வேறு எந்த "
    "உடலுக்குள் செய்யப்படும் பரிசோதனைகளும் செய்யப்படமாட்டாது.",
]:
    add_bullet(step)

add_heading("அபாயங்கள்:", level=3)
add_para("இந்த ஆய்வில் பங்கேற்பதால் எந்தவித உடல் நல அபாயமும் இல்லை. இது கேள்வித்தாளை மட்டும் அடிப்படையாகக் கொண்ட ஒரு கண்காணிப்பு (Observational) ஆய்வாகும்.")

add_heading("நன்மைகள்:", level=3)
add_para("இந்த ஆய்வில் பங்கேற்பதன் மூலம் உங்களுக்கு நேரடி மருத்துவ நன்மை கிடைக்காது. இருப்பினும், இந்த ஆய்வின் முடிவுகள் எதிர்காலத்தில் தோல் பூஞ்சைத் தொற்று நோயாளிகளுக்கான சிகிச்சை மற்றும் பராமரிப்பை மேம்படுத்த உதவக்கூடும்.")

add_heading("ரகசியத் தன்மை:", level=3)
add_para("உங்களிடமிருந்து பெறப்படும் அனைத்து தகவல்களும் முழுமையான ரகசியத்துடன் பாதுகாக்கப்படும். உங்கள் பெயர் அல்லது அடையாளம் எந்த ஆய்வு அறிக்கையிலும் அல்லது வெளியீட்டிலும் குறிப்பிடப்படாது.")

add_heading("தன்னார்வ பங்கேற்பு:", level=3)
add_para("இந்த ஆய்வில் பங்கேற்பது முற்றிலும் உங்கள் விருப்பம். நீங்கள் பங்கேற்க மறுக்கலாம் அல்லது எந்த நேரத்திலும் காரணம் கூறாமல் விலகலாம். இதனால் உங்கள் மருத்துவ சிகிச்சை அல்லது பராமரிப்பில் எந்தவித பாதிப்பும் ஏற்படாது.")

add_heading("தொடர்புக்கு:", level=3)
add_para(
    "டாக்டர். ஐ. ராஜதுரை, DVL துறை, MMCHRI, காஞ்சிபுரம். தொலைபேசி: +91 7401441069"
)

add_heading("நோயாளியின் ஒப்புதல் அறிக்கை:", level=3)
p = doc.add_paragraph()
r = p.add_run("நோயாளியின் பெயர்: ________________________________     வயது: __________________")
r.font.name = "Times New Roman"; r.font.size = Pt(12)

for item in [
    "மேலே கொடுக்கப்பட்டுள்ள தகவல்களை நான் படித்துள்ளேன் அல்லது அவை எனக்கு விளக்கிக் கூறப்பட்டுள்ளன என்பதை உறுதிப்படுத்துகிறேன்.",
    "இந்த ஆய்வில் பங்கேற்பது முற்றிலும் எனது விருப்பம் என்பதையும், எந்த நேரத்திலும் விலகிக்கொள்ளலாம் என்பதையும் நான் புரிந்துகொண்டுள்ளேன்.",
    "எனது தனிப்பட்ட விவரங்கள் மற்றும் அடையாளம் முழுமையான ரகசியத்துடன் பாதுகாக்கப்படும் என்பதை புரிந்துகொண்டுள்ளேன்.",
    "மேற்கண்ட அனைத்து தகவல்களையும் புரிந்துகொண்டு, இந்த ஆய்வில் தன்னார்வத்துடன் பங்கேற்க நான் சம்மதிக்கிறேன்.",
]:
    add_bullet(item)

doc.add_paragraph()
for sig_line in [
    "பங்கேற்பாளரின் கையொப்பம் / இடது கை பெருவிரல் ரேகை: ________________________     தேதி: ____________",
    "பெற்றோர் / பாதுகாவலரின் கையொப்பம் (தேவைப்பட்டால்): ________________________     தேதி: ____________",
    "சாட்சியின் கையொப்பம்: ________________________     தேதி: ____________",
    "ஆய்வாளரின் கையொப்பம்: ________________________     தேதி: ____________",
]:
    add_para(sig_line, space_after=6)

doc.add_page_break()

# ======================================================
# CASE PROFORMA
# ======================================================
add_heading("CASE PROFORMA", level=1, center=True)
add_para('Study: "A Clinico-Epidemiological Study on Quality of Life in Patients with Dermatophytosis Using DLQI"', bold=True)

add_heading("SECTION 1: PATIENT IDENTIFICATION", level=3)
for field in [
    "Study ID: __________     Hospital / OP No.: __________     Date: ______________",
    "Name: ___________________________     Age: ______     Sex:  \u25a1 Male   \u25a1 Female",
    "Occupation: _________________________     Education: _______________",
    "Socioeconomic Status:  \u25a1 Upper   \u25a1 Middle   \u25a1 Lower",
    "Address: _______________________________     Ph: _______________",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 2: CHIEF COMPLAINTS", level=3)
for field in [
    "Itching:  \u25a1 Yes   \u25a1 No     Duration: ____________",
    "Skin lesions:  \u25a1 Yes   \u25a1 No     Duration: ____________",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 3: HISTORY OF PRESENT ILLNESS", level=3)
for field in [
    "Duration of disease: ________________",
    "Episode:  \u25a1 First episode   \u25a1 Recurrent   If recurrent, number of episodes: _____",
    "Previous treatment:  \u25a1 Yes   \u25a1 No     Type: ___________________",
    "Similar complaints in family:  \u25a1 Yes   \u25a1 No",
    "Steroid / steroid-antifungal combination use:  \u25a1 Yes   \u25a1 No     Duration of misuse: ______",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 4: PAST HISTORY / CONFOUNDERS", level=3)
for field in [
    "Diabetes mellitus:  \u25a1 Yes   \u25a1 No",
    "Immunosuppression / Chronic illness:  \u25a1 Yes   \u25a1 No     Details: ___________",
    "Hypothyroidism:  \u25a1 Yes   \u25a1 No",
    "Family history of dermatophytosis:  \u25a1 Yes   \u25a1 No",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 5: GENERAL EXAMINATION", level=3)
for field in [
    "BP: ___________     PR: ___________     Weight: ___________     Height: ___________",
    "BMI: ___________",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 6: CLINICAL DETAILS OF DERMATOPHYTOSIS", level=3)
add_para("Type of Dermatophytosis (tick all that apply):", bold=True)
for ttype in [
    "\u25a1 Tinea corporis     \u25a1 Tinea cruris     \u25a1 Tinea faciei",
    "\u25a1 Tinea manuum     \u25a1 Tinea pedis     \u25a1 Tinea unguium",
    "\u25a1 Others: _______________",
]:
    add_para(ttype, indent=True, space_after=2)

for field in [
    "Number of sites: \u25a1 Single   \u25a1 Multiple (specify: _______)",
    "Body Surface Area (BSA) involved: _______ %",
    "Chronic (>6 months):  \u25a1 Yes   \u25a1 No",
    "Recurrent (recurrence within 6 weeks of completing treatment):  \u25a1 Yes   \u25a1 No",
    "Extensive (>10% BSA or multiple sites):  \u25a1 Yes   \u25a1 No",
]:
    add_para(field, indent=True, space_after=3)

add_heading("SECTION 7: DLQI QUESTIONNAIRE", level=3)
add_para(
    "Instructions: We would like to know how much your skin problem has affected you over the LAST WEEK. "
    "Please tick one box for each question. (0 = Not at all / Not relevant; 1 = A little; 2 = A lot; 3 = Very much)",
    size=11
)

dlqi_q_table = doc.add_table(rows=1, cols=3)
dlqi_q_table.style = "Table Grid"
make_table_header(dlqi_q_table, ["Q. No.", "Question (refer to last week)", "Score (0–3)"])
for qno, question in [
    ("Q1", "How itchy, sore, painful or stinging has your skin been?"),
    ("Q2", "How embarrassed or self-conscious have you been because of your skin?"),
    ("Q3", "How much has your skin interfered with you going shopping or looking after your home?"),
    ("Q4", "How much has your skin influenced the clothes you wear?"),
    ("Q5", "How much has your skin affected any social or leisure activities?"),
    ("Q6", "How much has your skin made it difficult for you to do any sport?"),
    ("Q7", "Has your skin prevented you from working or studying?\n(If 'No' – how much has it been a problem at work / school?)"),
    ("Q8", "How much has your skin created problems with your partner or any of your close friends or relatives?"),
    ("Q9", "How much has your skin caused any sexual difficulties?"),
    ("Q10", "How much of a problem has the treatment for your skin been, e.g. by making your home messy or by taking up time?"),
    ("TOTAL", "DLQI TOTAL SCORE (0–30)", ""),
]:
    row = dlqi_q_table.add_row()
    row.cells[0].text = qno
    row.cells[1].text = question
    row.cells[2].text = ""
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"
                run.font.size = Pt(10)

doc.add_paragraph()
add_para("Interpretation:", bold=True)
add_para("0–1: No effect on QoL   |   2–5: Small effect   |   6–10: Moderate effect   |   11–20: Very large effect   |   21–30: Extremely large effect")

doc.add_page_break()

# ======================================================
# CV FORMAT
# ======================================================
add_heading("FORMAT FOR CURRICULUM VITAE OF INVESTIGATOR(S)", level=1, center=True)

cv_table = doc.add_table(rows=0, cols=2)
cv_table.style = "Table Grid"
cv_fields = [
    ("Name", "Dr. RAJADURAI. I"),
    ("Present Affiliation", "Junior Resident, Dept. of DVL, MMCHRI, Kanchipuram"),
    ("Address", "MMCHRI, Kanchipuram"),
    ("Telephone Number", "+91 7401441069"),
    ("Email Address", "arunrajmkt@gmail.com"),
    ("Qualifications", "MBBS"),
    ("Years of Work Experience (after post-graduation)", "Currently pursuing PG"),
    ("Previous Affiliations (last 5 years)", "MBBS internship, MMCHRI"),
    ("Projects undertaken in last 5 years", "Nil prior to this"),
    ("Relevant Research Training / Experience",
     "Basic Research Methodology training; Human Participants Protection; "
     "ICMR GCP guidelines (training during PG orientation)"),
    ("Relevant Publications (last 5 years)", "Nil (first research project)"),
]
for label, value in cv_fields:
    row = cv_table.add_row()
    row.cells[0].text = label
    row.cells[1].text = value
    row.cells[0].paragraphs[0].runs[0].font.bold = True
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
p = doc.add_paragraph()
r = p.add_run("Signature: ________________________     Date: ____________")
r.font.name = "Times New Roman"; r.font.size = Pt(12)

doc.add_paragraph()
doc.add_paragraph()

add_heading("CV of Guide", level=2)
cv_guide = doc.add_table(rows=0, cols=2)
cv_guide.style = "Table Grid"
cv_guide_fields = [
    ("Name", "Dr. S. KUMARAVEL"),
    ("Present Affiliation", "Professor and Head of the Department, Dept. of DVL, MMCHRI, Kanchipuram"),
    ("Address", "Dept. of DVL, MMCHRI, Kanchipuram"),
    ("Telephone Number", "+91 9884646324"),
    ("Email Address", "kumaravel1959@gmail.com"),
    ("Qualifications", "MD (DVL)"),
    ("Years of Work Experience (after post-graduation)", "To be filled"),
    ("Previous Affiliations (last 5 years)", "MMCHRI, Kanchipuram"),
    ("Projects undertaken in last 5 years", "To be filled"),
    ("Relevant Research Training / Experience", "To be filled"),
    ("Relevant Publications (last 5 years)", "To be filled"),
]
for label, value in cv_guide_fields:
    row = cv_guide.add_row()
    row.cells[0].text = label
    row.cells[1].text = value
    row.cells[0].paragraphs[0].runs[0].font.bold = True
    for cell in row.cells:
        for p in cell.paragraphs:
            for run in p.runs:
                run.font.name = "Times New Roman"; run.font.size = Pt(11)

doc.add_paragraph()
p = doc.add_paragraph()
r = p.add_run("Signature: ________________________     Date: ____________")
r.font.name = "Times New Roman"; r.font.size = Pt(12)

# ======================================================
# UNDERTAKING
# ======================================================
doc.add_page_break()
add_heading("UNDERTAKING BY THE PRINCIPAL INVESTIGATOR", level=1, center=True)

add_label_value("1. Name of the Project",
    '"A Clinico-Epidemiological Study on Quality of Life in Patients with Dermatophytosis Using DLQI"')
add_para("2. Name, Designation and Department of the Principal Investigator:", bold=True)
for line in ["Dr. RAJADURAI. I", "Junior Resident",
             "Department of Dermatology, Venereology and Leprology",
             "Meenakshi Medical College Hospital & Research Institute, Kanchipuram"]:
    add_para(line, indent=True, space_after=2)

add_para("3. Undertaking:", bold=True, space_before=8)
add_para("I, Dr. RAJADURAI. I, Principal Investigator for the above study, hereby undertake that:")

for item in [
    "I will obtain IEC approval before commencing the study.",
    "I will adhere to the approved protocol and not make any amendments without prior IEC approval.",
    "I will obtain written informed consent from every participant before enrollment.",
    "I will maintain confidentiality of all participant data.",
    "I will report any adverse events or unanticipated problems to the IEC immediately.",
    "I will submit periodic progress reports and a final report to the IEC as required.",
    "I will publish the results of this study in a peer-reviewed journal within two years of completion.",
]:
    add_bullet(item)

doc.add_paragraph()
add_para("Signature of Principal Investigator: ___________________________")
add_para("Name: Dr. RAJADURAI. I")
add_para("Date: _______________")

# ======================================================
# SAVE
# ======================================================
output_path = "/tmp/workspace/iec-proposal/Rajadurai_IEC_Dermatophytosis_DLQI_MMCHRI.docx"
doc.save(output_path)
print(f"SUCCESS: Saved to {output_path}")

Successfully replaced 1 instance(s) of the string in '/tmp/workspace/iec-proposal/generate_rajadurai_iec.py'