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Refined Thesis Title Options

1. Spelling: "medovahsrotodusthi" should be "Medovaha Srotodushti" (or "Sroto Dushti")
2. Grammar: "an observation study" should be "An Observational Study"
3. Specificity: Gallbladder stones can be named using the Ayurvedic term (Pittashmari) or the modern term (Cholelithiasis) for academic precision

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Option 1 - Standard Academic (Recommended)

"An Observational Study of Medovaha Srotodushti Lakshana in Patients with Gallbladder Stones (Cholelithiasis)"

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Option 2 - With Ayurvedic Terminology for Gallbladder Stones

"An Observational Study of Medovaha Srotodushti Lakshana in Pittashmari (Cholelithiasis) Patients"

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Option 3 - Descriptive with Study Design Specified

"A Cross-Sectional Observational Study to Assess Medovaha Srotodushti Lakshana in Patients Diagnosed with Gallbladder Stones"

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Option 4 - Concise Version

"Medovaha Srotodushti Lakshana in Gallbladder Stone (Cholelithiasis) Patients: An Observational Study"

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Key Terminology Notes

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Assess vs. Evaluate

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Simple Examples

• Assess: "Assess the Medovaha Srotodushti Lakshana in gallbladder stone patients."
  • You are observing and recording which signs and symptoms are present.
• Evaluate: "Evaluate the effectiveness of Triphala in reducing Medovaha Srotodushti Lakshana."
  • You are judging whether the treatment worked or not.

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For Your Thesis

• "To Assess Medovaha Srotodushti Lakshana..." = correct for an observational study
• "To Evaluate..." = better suited for an interventional or treatment study

"An Observational Study to Assess Medovaha Srotodushti Lakshana in Patients with Gallbladder Stones (Cholelithiasis)"

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Diagnostic Criteria

For: "A Clinical Observational Study of Medovaha Srotodushti Lakshana in Patients of Cholelithiasis"

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A. MODERN DIAGNOSTIC CRITERIA (Cholelithiasis)

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1. Clinical Signs & Symptoms (Any 2 or more)

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2. Investigative Criteria (Mandatory - Gold Standard)

A) Ultrasonography (USG) Abdomen - MANDATORY

• Presence of hyperechoic foci with posterior acoustic shadowing in the gallbladder
• USG sensitivity: 95-97%, specificity: 95-99% (Gold Standard)
• Report must confirm: stone size, number, gallbladder wall thickness

B) Laboratory Investigations (Supportive)

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B. AYURVEDIC DIAGNOSTIC CRITERIA (Pittashmari)

Nidana (Causative Factors - Any 2)

Poorvaroopa (Prodromal Symptoms)

• Aruchi (anorexia)
• Gouravata (heaviness in abdomen)
• Tandra (drowsiness)

Roopa / Lakshana (Signs & Symptoms - Any 3)

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C. INCLUSION CRITERIA

1. Age between 18 to 70 years
2. Either gender (Male / Female)
3. USG abdomen confirmed diagnosis of Cholelithiasis
4. Presence of clinical symptoms of Pittashmari / Cholelithiasis
5. Patient willing to give written informed consent
6. Patients who have not undergone cholecystectomy (surgery)

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D. EXCLUSION CRITERIA

1. Acute cholecystitis requiring emergency surgery
2. Choledocholithiasis (CBD stones) with obstruction/jaundice
3. Carcinoma of gallbladder or biliary tract
4. Severe hepatic dysfunction (cirrhosis, hepatitis)
5. Pregnancy and lactating women
6. Patients with severe systemic illness (Cardiac, Renal failure)
7. Patients on long-term steroids or lipid-lowering drugs
8. Previously operated cases (post-cholecystectomy)
9. Age below 18 or above 70 years
10. Patients unwilling to participate

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E. WITHDRAWAL CRITERIA

• Patient develops acute complication requiring surgery
• Patient withdraws consent during study
• Development of any new serious illness during study

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Summary Table

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Modern Diagnostic Criteria for Cholelithiasis

(For Thesis: "A Clinical Observational Study of Medovaha Srotodushti Lakshana in Patients of Cholelithiasis")

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1. DEFINITION

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2. CLINICAL DIAGNOSTIC CRITERIA

A. Symptoms (Any one or more)

Reference: Lammert F, Gurusamy K, Ko CW, et al. Gallstones. Nat Rev Dis Primers. 2016;2:16024.

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B. Physical Examination Signs

Reference: Yokoe M, Takada T, Strasberg SM, et al. New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines. J Hepatobiliary Pancreat Sci. 2012;19:578-585.

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3. INVESTIGATIVE CRITERIA

A. IMAGING INVESTIGATIONS

i. Ultrasonography (USG) Abdomen - GOLD STANDARD (MANDATORY)

USG is the first-line and gold standard investigation for detection of gallbladder stones.

Reference: Fujita N, Yasuda I, Endo I, et al. Evidence-based clinical practice guidelines for cholelithiasis 2021. J Gastroenterol. 2023;58(9):801-833. [PMID: PMC10423145]

Reference: ACR Appropriateness Criteria - Right Upper Quadrant Pain (2022 Update). J Am Coll Radiol. 2023;20(5S):S211-S223.

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ii. Additional Imaging (when USG is inconclusive)

Reference: Fujita N et al., J Gastroenterol, 2023;58:801-833.

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B. LABORATORY INVESTIGATIONS

Reference: Lammert F, Wittenburg H. Gallstones: Prevention, Diagnosis, and Treatment. Semin Liver Dis. 2024;44(3):394-404.

Reference: European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016;65(1):146-181.

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4. CONFIRMED DIAGNOSIS

USG abdomen shows hyperechoic lesion(s) with posterior acoustic shadowing in the gallbladder, with or without clinical symptoms.

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5. CLASSIFICATION OF GALLSTONES (for record in thesis)

Reference: EASL Clinical Practice Guidelines. J Hepatol. 2016;65(1):146-181.

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KEY REFERENCES FOR YOUR THESIS

1. Fujita N, Yasuda I, Endo I, et al. Evidence-based clinical practice guidelines for cholelithiasis 2021. Journal of Gastroenterology. 2023;58(9):801-833.
2. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. Journal of Hepatology. 2016;65(1):146-181.
3. Lammert F, Gurusamy K, Ko CW, et al. Gallstones. Nature Reviews Disease Primers. 2016;2:16024.
4. Lammert F, Wittenburg H. Gallstones: Prevention, Diagnosis, and Treatment. Seminars in Liver Disease. 2024;44(3):394-404.
5. ACR Appropriateness Criteria - Right Upper Quadrant Pain: 2022 Update. Journal of American College of Radiology. 2023;20(5S):S211-S223.
6. Yokoe M, Takada T, Strasberg SM, et al. Revised Tokyo Guidelines - Diagnostic criteria for acute cholecystitis. J Hepatobiliary Pancreat Sci. 2012;19:578-585.
7. MSD Manual Professional Edition - Cholelithiasis. Merck Sharp & Dohme Corp. (msdmanuals.com)

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CRITERIA FOR ASSESSMENT

Thesis: "A Clinical Observational Study of Medovaha Srotodushti Lakshana in Patients of Cholelithiasis"

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Note: Since this is an observational study, assessment is done to record and grade the presence and severity of Medovaha Srotodushti Lakshana in Cholelithiasis patients - NOT to judge a treatment outcome. A 0-3 grading scale (standard in Ayurveda research) is used.

Grading Key (applies to all symptoms below):

Grade	Meaning
0	Absent
1	Mild (present but does not interfere with daily activity)
2	Moderate (interferes with daily activity)
3	Severe (unable to perform daily activity)

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SECTION A - ASSESSMENT OF MEDOVAHA SROTODUSHTI LAKSHANA

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A1. SROTO DUSHTI PRAKAR (Types of Srotas Vitiation)

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A2. MEDOVAHA SROTODUSHTI LAKSHANA - GRADING TABLE

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A3. SPECIFIC LAKSHANA RELATED TO CHOLELITHIASIS (Pittashmari context)

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SECTION B - MODERN CLINICAL ASSESSMENT PARAMETERS

B1. ANTHROPOMETRIC MEASUREMENTS

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B2. LABORATORY PARAMETERS

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B3. USG ABDOMEN FINDINGS (Record from report)

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SECTION C - SCORING SUMMARY SHEET

Interpretation of Total Score:

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REFERENCES

1. WHO-DFC Sponsored Project - Developing Guidelines for Clinical Research Methodology in Ayurveda. Prof. Rajagopala S, IPGT & RA, Gujarat Ayurved University, Jamnagar, 2011. (Standard Ayurveda symptom grading reference)
2. Charaka Samhita, Sutrasthana 28 - Medovaha Srotas Dushti Lakshana
3. Ashtanga Hridayam, Sutrasthana 11 - Srotas Dushti Prakar
4. Sushruta Samhita, Nidanasthana - Pittashmari Lakshana
5. WHO Expert Committee - BMI Classification for adults. WHO Technical Report Series, Geneva.
6. Lammert F, Gurusamy K, Ko CW, et al. Gallstones. Nat Rev Dis Primers. 2016;2:16024.

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MATERIAL AND METHODS

Thesis: "A Clinical Observational Study of Medovaha Srotodushti Lakshana in Patients of Cholelithiasis"

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1. SOURCE OF DATA

• OPD (Out Patient Department) and IPD (In Patient Department) of [Your Ayurvedic College & Hospital Name]
• Patients referred from Radiology/Pathology departments with confirmed USG diagnosis of Cholelithiasis

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2. STUDY DESIGN

Justification of Sample Size:

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3. SAMPLING METHOD

• Type: Purposive / Convenience Sampling
• Patients presenting to OPD/IPD with USG-confirmed Cholelithiasis will be screened and enrolled after applying inclusion and exclusion criteria
• Written informed consent will be obtained from all enrolled patients

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4. INCLUSION CRITERIA

1. Patients of either gender (Male / Female)
2. Age group: 18 to 70 years
3. USG abdomen-confirmed diagnosis of Cholelithiasis (gallbladder stones)
4. Presence of at least one clinical symptom of Cholelithiasis
5. Patients willing to participate and provide written informed consent
6. Patients who have not undergone cholecystectomy

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5. EXCLUSION CRITERIA

1. Age below 18 years or above 70 years
2. Acute Cholecystitis requiring emergency surgical intervention
3. Choledocholithiasis (CBD stones) with obstructive jaundice needing ERCP
4. Carcinoma of the gallbladder or biliary tract
5. Severe hepatic disorders (Cirrhosis, Acute Viral Hepatitis)
6. Pregnancy and lactating women
7. Patients with severe systemic illness (Chronic Renal Failure, Cardiac failure, Malignancy)
8. Patients on long-term steroid therapy or lipid-lowering drugs (statins)
9. Post-cholecystectomy patients
10. Patients unwilling to give informed consent

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6. WITHDRAWAL CRITERIA

1. Patient develops an acute surgical complication during the study period
2. Patient voluntarily withdraws consent
3. Patient develops a serious intercurrent illness
4. Non-compliance with study visits

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7. STUDY MATERIAL

A. Primary Tool - Case Proforma

• Demographic data
• Chief complaints and history
• Nidana (causative factors) - Ayurvedic
• Poorvaroopa and Roopa (Ayurvedic signs & symptoms)
• Medovaha Srotodushti Lakshana grading sheet (0-3 scale)
• Physical examination findings
• Anthropometric measurements
• Laboratory investigation records
• USG abdomen report

B. Equipment / Instruments Used

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8. METHODS OF DATA COLLECTION

Step 1 - Screening

• All patients presenting with complaints suggestive of Cholelithiasis will be screened
• USG abdomen report will be checked for confirmation of diagnosis

Step 2 - Enrollment

• Patients fulfilling inclusion criteria will be enrolled
• Written informed consent will be obtained in the patient's vernacular language

Step 3 - History Taking

• Name, Age, Gender, Occupation, Address
• Religion, Marital status, Socioeconomic status

• Onset, duration, progression, aggravating and relieving factors

• Any previous episodes, hospitalization, surgeries

• Gallstone disease, obesity, diabetes, dyslipidemia in family members

• Type of diet (vegetarian / non-vegetarian)
• Frequency of fatty/oily food intake
• Physical activity level
• Sleep patterns (Divaswapna)
• Alcohol / tobacco use

Step 4 - Clinical Examination

• General appearance, built, nourishment
• Pallor, Icterus (jaundice), Cyanosis, Clubbing, Oedema, Lymphadenopathy

• Pulse, Blood Pressure, Respiratory Rate, Temperature

• Height, Weight, BMI
• Waist circumference, Hip circumference, Waist-Hip Ratio (WHR)

• Abdominal examination - inspection, palpation, percussion, auscultation
• Murphy's Sign
• RUQ tenderness

Step 5 - Ayurvedic Examination (Ashtavidha Pariksha)

• Prakriti, Vikriti, Sara, Samhanana, Pramana, Satmya, Satva, Aahara Shakti, Vyayama Shakti, Vaya

Step 6 - Assessment of Medovaha Srotodushti Lakshana

Step 7 - Investigations

• USG Abdomen (for confirmation and stone characterization)

• CBC (Complete Blood Count)
• Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)
• LFT (Liver Function Test) - Bilirubin, ALP, SGOT, SGPT
• FBS / PPBS (Blood Sugar)
• Urine Routine & Microscopy

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9. STATISTICAL ANALYSIS

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10. ETHICAL CONSIDERATIONS

1. Ethical clearance will be obtained from the Institutional Ethics Committee (IEC) before commencement of the study
2. The study will be conducted according to ICMR Guidelines for Biomedical Research (2017)
3. Written informed consent will be obtained from all participants in vernacular language
4. Participation is voluntary and withdrawal will not affect patient's treatment
5. Patient confidentiality will be maintained at all times - data will be coded
6. The study will be registered with CTRI (Clinical Trials Registry - India)
7. No invasive procedures will be performed beyond routine clinical investigations

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11. OPERATIONAL DEFINITIONS

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12. FLOW CHART OF THE STUDY

Patients presenting to OPD/IPD
           ↓
    Screening for Cholelithiasis
    (History + USG Report)
           ↓
  Apply Inclusion / Exclusion Criteria
           ↓
      Eligible Patients (n = 60)
           ↓
   Written Informed Consent
           ↓
  Detailed History & Examination
  (Ayurvedic + Modern)
           ↓
  Ashtavidha / Dashavidha Pariksha
           ↓
  Grading of Medovaha Srotodushti
  Lakshana (0-3 scale)
           ↓
  Laboratory Investigations
  + USG abdomen report
           ↓
  Data Recording in Case Proforma
           ↓
  Statistical Analysis
           ↓
  Results & Observations
           ↓
  Discussion & Conclusion

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REFERENCES

1. ICMR Guidelines for Biomedical and Health Research Involving Human Participants, Indian Council of Medical Research, New Delhi, 2017.
2. CCIM (Central Council of Indian Medicine) - Guidelines for PG Research in Ayurveda.
3. WHO-DFC - Developing Guidelines for Clinical Research Methodology in Ayurveda. Prof. Rajagopala S, Gujarat Ayurved University, Jamnagar, 2011.
4. Charaka Samhita, Sutrasthana 28/7 - Medovaha Srotas Dushti Lakshana.
5. Ashtanga Hridayam, Sutrasthana 11 - Srotodushti Prakar.
6. Fujita N, Yasuda I, Endo I, et al. Evidence-based clinical practice guidelines for cholelithiasis 2021. J Gastroenterol. 2023;58(9):801-833.
7. STROBE Statement - Strengthening the Reporting of Observational Studies in Epidemiology. Lancet. 2007;370:1453-1457.

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EXPECTED OUTCOMES

Thesis: "A Clinical Observational Study of Medovaha Srotodushti Lakshana in Patients of Cholelithiasis"

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1. PRIMARY EXPECTED OUTCOMES

1.1 Documentation of Medovaha Srotodushti Lakshana in Cholelithiasis Patients

• Which Lakshanas are most frequently present
• The degree of severity (mild / moderate / severe) of each Lakshana
• The frequency and percentage of each Lakshana in the study population

1.2 Most Commonly Expected Lakshanas

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2. SECONDARY EXPECTED OUTCOMES

2.1 Correlation Between Medovaha Srotodushti Score and Modern Parameters

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2.2 Demographic Profile Findings

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2.3 Nidana (Causative Factors) Profile

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2.4 Prakriti Distribution

• Kapha-Pitta Prakriti patients will be in the majority among Cholelithiasis patients
• This aligns with Ayurvedic understanding that Kaphaja and Pittaja conditions underlie both Medo Dushti and Pittashmari formation

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2.5 USG Findings Correlation

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3. ACADEMIC / SCIENTIFIC SIGNIFICANCE OF EXPECTED OUTCOMES

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4. WHAT THE STUDY DOES NOT CLAIM

• The study will NOT claim causation - only association
• The study will NOT evaluate any treatment or intervention
• The study will NOT predict prognosis
• Findings will be limited to the study population and may not be universally generalizable

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5. SUMMARY OF EXPECTED OUTCOMES

Cholelithiasis Patients
        ↓
Majority expected to show Medovaha Srotodushti Lakshana
        ↓
Most common: Atisthoulya, Anga Gaurava, Alasya,
             Parshva Shoola, Snigdha Twak, Adhmana
        ↓
Positive correlation expected with:
BMI ↑, Lipid Profile ↑, WHR ↑
        ↓
Female, 30-50 yrs, Kapha-Pitta Prakriti predominance
        ↓
Validates Ayurvedic concept of Medo Dushti
in Cholelithiasis pathogenesis

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REFERENCES

1. Charaka Samhita, Sutrasthana 28 - Medovaha Srotas Dushti Lakshana
2. Ashtanga Hridayam, Sutrasthana 11 - Srotodushti
3. Lammert F, Gurusamy K, Ko CW, et al. Gallstones. Nat Rev Dis Primers. 2016;2:16024.
4. EASL Clinical Practice Guidelines on gallstones. J Hepatol. 2016;65(1):146-181.
5. Portincasa P, Moschetta A, Palasciano G. Cholesterol gallstone disease. Lancet. 2006;368(9531):230-239.
6. Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012;6(2):172-187.

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