Assessment Parameters and Outcome Measures ________________________________________ Clinical Assessment Parameters Ayurvedic Clinical Assessment — Vataja Pratishyaya Lakshana Score Each symptom scored 0–3 at every visit (Week 0, 6, 12, 24): Lakshana Grade 0 Grade 1 (Mild) Grade 2 (Moderate) Grade 3 (Severe) Kshavatha (Sneezing) Absent 1–3 bouts/day 4–7 bouts/day >7 bouts/day Panitoya Nibha Srava (Watery discharge) Absent Occasional, mild Frequent, moderate Constant, profuse Peenasa (Nasal obstruction) Absent Mild, unilateral Moderate, bilateral Severe, mouth breathing Nasa Kandu (Nasal pruritus) Absent Occasional, no rubbing Frequent rubbing Constant, disturbs sleep Shiroruk (Headache) Absent Mild, occasional Moderate, frequent Severe, activity-limiting Total Vataja Pratishyaya Lakshana Score: 0–15 (Higher score = greater disease severity) ________________________________________ Total Nasal Symptom Score (TNSS) — Validated Modern Tool Per ICAR-AR 2023 (Wise SK et al., PMID: 36878860): Symptom Grade 0 Grade 1 Grade 2 Grade 3 Nasal congestion None Mild, barely noticeable Moderate, bothersome Severe, significantly impairs daily activities Rhinorrhoea None Mild, occasional sniffling Moderate, frequent blowing Severe, constant Sneezing None Mild, 1–3 sneezes/episode Moderate, 4–7 sneezes Severe, incapacitating Nasal pruritus None Mild, occasional Moderate, frequent rubbing Severe, constant Total TNSS: 0–12 (higher = more severe) clinically meaningful improvement = reduction of ≥1.5 points from baseline Assessment: Week 0, 6, 12, 24 ________________________________________ A.3 Visual Analogue Scale (VAS) • Tool: 100 mm horizontal line; left end = "no symptoms"; right end = "worst possible symptoms" • Rated by: Parent (children <7 years); parent + child (≥7 years) • Scale: 0–100 mm • Categorisation: 0–25 mm = mild; 26–50 mm = moderate; 51–100 mm = severe • Assessment: Week 0, 6, 12, 24 A.4 Vyadhikshamatva Assessment Scale — Ayurvedic Immunity Validated tool for Ayurvedic clinical research, assessed at Week 0, 12, 24: Parameter Scoring Criteria Maximum Score Frequency of respiratory infections in past 3 months 0 = ≥4 episodes; 1 = 3 episodes; 2 = 2 episodes; 3 = 1 episode; 4 = none 4 Severity of illness episodes 0 = hospitalisation needed; 1 = severe; 2 = moderate; 3 = mild; 4 = none 4 Recovery time from illness 0 = >14 days; 1 = 10–14 days; 2 = 7–10 days; 3 = 4–7 days; 4 = <4 days 4 Agni (Appetite and digestion) 0 = poor/absent; 1 = low; 2 = moderate; 3 = good; 4 = excellent 4 Bala (Physical activity and vitality) 0 = bedridden; 1 = very limited; 2 = moderately limited; 3 = mildly limited; 4 = full activity 4 Skin and complexion (Varna) 0 = dull, pallor; 1 = slightly dull; 2 = normal; 3 = good; 4 = excellent 4 Sleep quality (Nidra) 0 = severely disturbed; 1 = moderately disturbed; 2 = mildly disturbed; 3 = mostly normal; 4 = normal 4 Total Vyadhikshamatva Score: 0–28 (higher = better immunity) A.5 Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) • Tool: Validated 28-item parent-proxy questionnaire for children <12 years • Domains (7): Nasal symptoms, Eye symptoms, Practical problems, Activity limitations, Other symptoms, Nose blowing, Sleep • Scoring: Each item 0–6 (0 = not troubled;preparehortutcomeeasuresoeastednortalithoutables
Pediatric Rhinoconjunctivitis Quality of Life Questionnaire PRQLQ scoring domains validated
allergic rhinitis outcome measures TNSS VAS clinical trial assessment pediatric
Assessment Parameters and Outcome Measures
Clinical Assessment Parameters
A.1 Ayurvedic Clinical Assessment — Vataja Pratishyaya Lakshana Score
| Lakshana | Grade 0 | Grade 1 (Mild) | Grade 2 (Moderate) | Grade 3 (Severe) |
|---|---|---|---|---|
| Kshavatha (Sneezing) | Absent | 1–3 bouts/day | 4–7 bouts/day | >7 bouts/day |
| Panitoya Nibha Srava (Watery discharge) | Absent | Occasional, mild | Frequent, moderate | Constant, profuse |
| Peenasa (Nasal obstruction) | Absent | Mild, unilateral | Moderate, bilateral | Severe, mouth breathing |
| Nasa Kandu (Nasal pruritus) | Absent | Occasional, no rubbing | Frequent rubbing | Constant, disturbs sleep |
| Shiroruk (Headache) | Absent | Mild, occasional | Moderate, frequent | Severe, activity-limiting |
A.2 Total Nasal Symptom Score (TNSS) — Validated Modern Tool
| Symptom | Grade 0 | Grade 1 | Grade 2 | Grade 3 |
|---|---|---|---|---|
| Nasal congestion | None | Mild, barely noticeable | Moderate, bothersome | Severe, significantly impairs daily activities |
| Rhinorrhoea | None | Mild, occasional sniffling | Moderate, frequent blowing | Severe, constant |
| Sneezing | None | Mild, 1–3 sneezes/episode | Moderate, 4–7 sneezes | Severe, incapacitating |
| Nasal pruritus | None | Mild, occasional | Moderate, frequent rubbing | Severe, constant |
- Total TNSS: 0–12 (higher = more severe)
- Clinically meaningful improvement: reduction of ≥1.5 points from baseline
- Assessment: Week 0, 6, 12, 24
A.3 Visual Analogue Scale (VAS)
- Tool: 100 mm horizontal line; left end = "no symptoms"; right end = "worst possible symptoms"
- Rated by: Parent (children <7 years); parent + child (≥7 years)
- Scale: 0–100 mm
- Categorisation: 0–25 mm = mild; 26–50 mm = moderate; 51–100 mm = severe
- Clinically significant change: ≥23 mm from baseline (validated per ICAR-AR; Rhinitis guidelines, p. 22)
- Assessment: Week 0, 6, 12, 24
A.4 Vyadhikshamatva Assessment Scale — Ayurvedic Immunity
| Parameter | Scoring Criteria | Maximum Score |
|---|---|---|
| Frequency of respiratory infections (past 3 months) | 0 = ≥4 episodes; 1 = 3 episodes; 2 = 2 episodes; 3 = 1 episode; 4 = none | 4 |
| Severity of illness episodes | 0 = hospitalisation needed; 1 = severe; 2 = moderate; 3 = mild; 4 = none | 4 |
| Recovery time from illness | 0 = >14 days; 1 = 10–14 days; 2 = 7–10 days; 3 = 4–7 days; 4 = <4 days | 4 |
| Agni (Appetite and digestion) | 0 = poor/absent; 1 = low; 2 = moderate; 3 = good; 4 = excellent | 4 |
| Bala (Physical activity and vitality) | 0 = bedridden; 1 = very limited; 2 = moderately limited; 3 = mildly limited; 4 = full activity | 4 |
| Skin and complexion (Varna) | 0 = dull, pallor; 1 = slightly dull; 2 = normal; 3 = good; 4 = excellent | 4 |
| Sleep quality (Nidra) | 0 = severely disturbed; 1 = moderately disturbed; 2 = mildly disturbed; 3 = mostly normal; 4 = normal | 4 |
A.5 Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
- Tool: Validated 28-item parent-proxy questionnaire for children <12 years (Juniper EF et al.)
- Domains (7): Nasal symptoms, Eye symptoms, Practical problems, Activity limitations, Other symptoms, Nose blowing, Sleep
- Scoring: Each item 0–6 (0 = not troubled at all; 6 = extremely troubled)
- Domain score: Mean of items within that domain (range 0–6)
- Overall PRQLQ score: Mean of all 28 items (range 0–6; higher = worse quality of life)
- Minimum clinically important difference (MCID): 0.5 units on the overall score
- Rater: Parent/caregiver proxy for children <7 years; combined parent + child report for children 7–12 years
- Assessment: Week 0, 6, 12, 24
A.6 Rhinitis Control Assessment Test (RCAT) (optional supplementary measure)
- Tool: 6-item validated patient-reported outcome instrument
- Scale: 6–30 (scores ≤21 indicate inadequate rhinitis control)
- Assessment: Week 0, 12, 24
Biochemical / Objective Assessment Parameters
B.1 Serum Total IgE
- Method: Chemiluminescent immunoassay (CLIA)
- Reference range (pediatric): Age-adjusted; elevation supports atopic aetiology
- Assessment: Week 0, 24
B.2 Absolute Eosinophil Count (AEC)
- Method: Automated haematology analyser (differential leucocyte count)
- Normal: 100–500 cells/µL
- Assessment: Week 0, 24
B.3 Nasal Smear Cytology (Nasal Eosinophilia)
- Method: Anterior rhinoscopy swab / anterior nasal scraping; Hansel stain
- Grading:
- Grade 0: No eosinophils
- Grade 1: 1–5 eosinophils/high-power field (HPF)
- Grade 2: 6–15 eosinophils/HPF
- Grade 3: >15 eosinophils/HPF
- Assessment: Week 0, 24
Safety Assessment Parameters
C.1 Adverse Events (AE) Monitoring
- Recorded at every visit (Week 0, 6, 12, 24) and between visits via caregiver-reported diary
- Classified by: nature, onset, duration, severity (mild/moderate/severe), relatedness to study intervention
- Grading per CTCAE v5.0
C.2 Routine Safety Investigations
| Investigation | Timing |
|---|---|
| Complete Blood Count (CBC) with differential | Week 0, 24 |
| Liver Function Tests (LFT): AST, ALT, ALP, total bilirubin | Week 0, 24 |
| Renal Function Tests (RFT): serum creatinine, BUN | Week 0, 24 |
| Urine Routine & Microscopy | Week 0, 24 |
C.3 Vital Signs
- Height, weight (BMI-for-age), pulse rate, blood pressure, respiratory rate
- Assessed at every visit (Week 0, 6, 12, 24)
Summary of Outcome Measures and Assessment Schedule
| Outcome Measure | Week 0 | Week 6 | Week 12 | Week 24 |
|---|---|---|---|---|
| Vataja Pratishyaya Lakshana Score | ✓ | ✓ | ✓ | ✓ |
| TNSS | ✓ | ✓ | ✓ | ✓ |
| VAS | ✓ | ✓ | ✓ | ✓ |
| Vyadhikshamatva Score | ✓ | — | ✓ | ✓ |
| PRQLQ | ✓ | ✓ | ✓ | ✓ |
| Serum Total IgE | ✓ | — | — | ✓ |
| AEC | ✓ | — | — | ✓ |
| Nasal Smear Cytology | ✓ | — | — | ✓ |
| Safety labs (CBC, LFT, RFT, Urine) | ✓ | — | — | ✓ |
| Vital Signs | ✓ | ✓ | ✓ | ✓ |
| Adverse Event recording | ✓ | ✓ | ✓ | ✓ |
- Primary outcome: Change in TNSS from baseline to Week 24
- Key secondary outcomes: Vataja Pratishyaya Lakshana Score, VAS, PRQLQ overall score, Vyadhikshamatva Score
- Exploratory/biological outcomes: Serum IgE, AEC, nasal smear eosinophilia
ब्राह्मीसिद्धार्थकवचासारिवाकुष्ठसैन्धवैः । सकणैः साधितं पीतं वामेधास्मृतिकृद् घृतम् । आयुष्यं पाप्मरक्षोघ्नं भूतोन्मादनिबर्हणम् ।।" prepare drug ingredients parts used for ghrita preparation latin name quantity in parts preparebramhi ghrita preparation as part of swarnaprashan
Brahmi Ghrita ingredients preparation classical Ayurveda formulation
Swarnaprashan ghrita preparation Swarna Bindu Prashan pediatric Ayurveda
Brahmi Ghrita — Classical Reference & Drug Ingredient Profile
Source Shloka (Identified Reference)
- Vacha (Medhya — cognitive enhancement)
- Smriti (memory improvement)
- Aayushya (longevity)
- Paapma hara (sin/disease-removing)
- Rakshogna (antimicrobial/protective)
- Bhutonmada nibarhanam (psychiatric disease management)
Shloka — Ingredient Identification
"ब्राह्मीसिद्धार्थकवचासारिवाकुष्ठसैन्धवैः । सकणैः साधितं पीतं वामेधास्मृतिकृद् घृतम् ।"
Drug Ingredients — Parts Used, Latin Names & Quantity
| # | Sanskrit Name | Common Name | Botanical/Latin Name | Family | Part Used | Classical Quantity (Parts) |
|---|---|---|---|---|---|---|
| 1 | Brahmi | Brahmi / Indian Pennywort | Bacopa monnieri (L.) Pennell (primary) / Centella asiatica (L.) Urban (secondary) | Plantaginaceae / Apiaceae | Whole plant (Panchanga) | 1 part |
| 2 | Siddharthaka | White mustard | Sinapis alba Linn. (Brassica alba) | Brassicaceae | Seeds (Beeja) | 1 part |
| 3 | Vacha | Sweet flag / Calamus | Acorus calamus Linn. | Acoraceae | Rhizome (Kanda) | 1 part |
| 4 | Sariva | Indian sarsaparilla | Hemidesmus indicus (L.) R.Br. | Apocynaceae | Root (Mula) | 1 part |
| 5 | Kushtha | Costus / Saussurea | Saussurea lappa (Decne.) C.B.Clarke (Syn. S. costus) | Asteraceae | Root (Mula) | 1 part |
| 6 | Saindhava | Rock salt / Sindh salt | Sodium chloride (mineral, not botanical) | — | Crystalline mineral | 1 part |
| 7 | Kana (सकणैः) | Long pepper | Piper longum Linn. | Piperaceae | Fruit (Phala) | 1 part |
| — | Ghrita (Base) | Cow's ghee | Clarified butter — Bos taurus | — | Processed clarified butter | 4 parts (Sneha base) |
Classical proportion for Ghrita kalpana:
- Kalka (paste of drugs): 1 part
- Sneha (ghee): 4 parts
- Drava (liquid/kashaya or water): 16 parts (Per Sharangdhara Samhita Madhyama Khanda 9 — Sneha Paka Vidhi)
Preparation Method — Brahmi Ghrita (Sneha Paka Vidhi)
Step 1: Kalka (Drug Paste) Preparation
- All 7 ingredients taken in equal parts (1:1:1:1:1:1:1)
- Total drug combination reduced to fine paste using Gomutra (cow's urine) or plain water as trituration medium
- Kalka quantity: 1 part of the total Ghrita base weight
Step 2: Drava (Liquid Medium) Preparation
- Prepare a Kashaya (decoction) of Brahmi, Vacha, and Sariva
- Standard decoction ratio: 1 part drug : 16 parts water, reduced to ¼ (i.e., 4 parts)
- Alternatively: Gomutra used as Drava for Unmada indications (per Ashtanga Hridayam)
Step 3: Sneha Paka (Ghrita Processing)
| Stage | Detail |
|---|---|
| Vessel | Heavy-bottomed copper or iron vessel (Kalai-lined) |
| Sequence | Add Ghrita (4 parts) → add Kalka → add Drava (16 parts) |
| Heat | Moderate, continuous stirring (Mridu Agni) |
| Paka Pariksha | Varti Pariksha — Kalka rolls into non-sticky wick without smoke = Madhyama Paka (optimal) |
| Endpoint signs | Ghrita becomes clear, Kalka forms non-sticky varti, characteristic aroma |
| Filtration | Filter through double-layered muslin cloth while warm |
| Storage | Store in clean glass/ceramic container, away from light and moisture |
Brahmi Ghrita as a Component of Swarnaprashan
What is Swarnaprashan?
"सुवर्णं प्राशयेत् धात्र्या स्तन्यसिक्तं मधुसर्पिषा" — Kashyapa Samhita
Composition of Swarnaprashan with Brahmi Ghrita Base
| Ingredient | Latin / Source | Part / Form | Quantity |
|---|---|---|---|
| Swarna Bhasma (Gold ash) | Aurum — purified, incinerated gold | Bhasma | 1 part (approx. 15–30 mg per dose; 1 mg/kg body weight in practice) |
| Brahmi Ghrita | As prepared above | Processed ghee | Vehicle/base — as required for mixing |
| Madhu (Honey) | Apis mellifera / Apis dorsata | Raw unprocessed honey | 2 parts |
| Vacha Churna | Acorus calamus | Root powder | Optional — ¼ part |
| Ashwagandha Churna | Withania somnifera (L.) Dunal | Root powder | Optional — ¼ part |
| Shankha Pushpi | Convolvulus pluricaulis Chois. | Whole plant powder | Optional — ¼ part |
Critical rule: In Swarnaprashan, honey and ghee must NEVER be mixed in equal proportions (Viruddha Ahara principle per Charaka Samhita Sutrasthana 26). Madhu is always used in greater quantity than Ghrita (2:1 ratio minimum).
Swarnaprashan Dose & Administration
| Age Group | Swarna Bhasma Dose | Frequency | Duration |
|---|---|---|---|
| Neonates (0–1 month) | 15 mg | Daily for 30 days, then Pushya Nakshatra | Minimum 1 year |
| Infants (1–12 months) | 15–30 mg | Pushya Nakshatra (every 27 days) or daily | As per Prakriti |
| 1–5 years | 30 mg | Pushya Nakshatra / daily | As per protocol |
| 5–16 years | 30–60 mg | Pushya Nakshatra | As per protocol |
- Route: Oral (Prashana/Lehana — licking from finger or spoon)
- Timing: Early morning, empty stomach, preferably on Pushya Nakshatra day
- Anupana: Breast milk in neonates; warm water or milk in older children
Indicated Benefits of Brahmi Ghrita-Based Swarnaprashan
| Classical Claim | Modern Interpretation |
|---|---|
| Medhakara (मेधाकर) | Cognitive enhancement, neuroplasticity support |
| Smritikara (स्मृतिकर) | Memory consolidation, cholinergic activity (Bacopa alkaloids) |
| Aayushya (आयुष्य) | Adaptogenic/antioxidant — longevity |
| Rakshogna (रक्षोघ्न) | Antimicrobial (Vacha, Kushtha), immune-boosting |
| Bhutonmada nibarhanam | CNS stabilisation, antiepileptic (Acorus calamus) |
| Vyadhikshamatva | Immunomodulation via Swarna Bhasma + Medhya Rasayana combination |
Quality Control Parameters for Brahmi Ghrita (as per API/AFI standards)
| Parameter | Specification |
|---|---|
| Colour | Pale yellow to golden yellow |
| Odour | Characteristic, pleasant |
| Refractive Index | 1.456–1.464 |
| Saponification value | 218–235 |
| Iodine value | 25–38 |
| Free fatty acid (as oleic acid) | NMT 0.5% |
| Acid value | NMT 1.0 |
| Thin Layer Chromatography | Characteristic spots for Bacoside A (Brahmi), Asarone (Vacha) |
| Heavy metal testing | As per API Schedule E1 limits |