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Effect of Vasadi Kwath in the Management of Timir w.s.r. to Diabetic Retinopathy – A Clinical Study timir study protocol according to ahurveda n modern

Study Protocol (Ayurveda + Modern) Title: Effect of Vasadi Kwath in the Management of Timir with special reference to Non-Proliferative Diabetic Retinopathy (NPDR): A Randomized Controlled Clinical Study

1. Background and Rationale

In Ayurveda, Timir is a Drishtigata Roga involving progressive impairment of vision due to vitiation of Dosha and involvement of Dushya in Netra. Diabetic retinopathy (DR), especially NPDR, presents with gradual visual decline, microvascular changes, and retinal damage. Conceptually, DR can be correlated with Timir with Madhumehajanya pathogenesis involving Rakta, Meda, Majja, and Ojas disturbance.
Vasadi Kwath is traditionally indicated in eye disorders and may have potential Chakshushya, Raktaprasadana, Pitta-Kapha shamana, anti-inflammatory, and microcirculatory supportive actions. This study evaluates its clinical efficacy and safety in NPDR.

2. Aim

To evaluate the effect of Vasadi Kwath in management of Timir (w.s.r. NPDR in type 2 diabetes mellitus).

3. Objectives

Primary Objective

  • To assess change in diabetic retinopathy severity and visual function after treatment with Vasadi Kwath.

Secondary Objectives

  • To assess effect on:
    • Best corrected visual acuity (BCVA)
    • Central macular thickness (OCT)
    • Fundus findings (microaneurysms, hemorrhages, hard exudates, cotton wool spots)
    • Vision-related quality of life
    • Glycemic parameters (HbA1c, FBS, PPBS)
    • Ayurvedic symptom score of Timir
  • To evaluate safety (LFT, RFT, adverse events).

4. Hypothesis

  • Null (H0): Vasadi Kwath + standard diabetic care has no additional benefit over control in NPDR.
  • Alternative (H1): Vasadi Kwath + standard diabetic care provides significant additional benefit in NPDR.

5. Study Design

  • Prospective, randomized, controlled, parallel-arm, assessor-blinded clinical trial
  • Study duration per participant: 16 weeks
    • 12 weeks intervention
    • 4 weeks follow-up
  • Setting: Ayurveda hospital with ophthalmology support (integrative setup)

6. Participants

Inclusion Criteria

  1. Age 30–70 years
  2. Diagnosed type 2 diabetes mellitus
  3. Mild to moderate NPDR (ETDRS criteria) in at least one eye
  4. BCVA range: 6/9 to 6/60 (study eye)
  5. HbA1c 6.5% to 10%
  6. Willingness to continue standard antidiabetic treatment
  7. Written informed consent

Exclusion Criteria

  1. Proliferative DR / clinically significant macular edema requiring urgent laser/injection
  2. Other major ocular disorders (advanced glaucoma, mature cataract, uveitis, retinal vein occlusion)
  3. Recent ocular surgery (<6 months)
  4. Uncontrolled hypertension (>180/110 mmHg)
  5. Severe renal/hepatic/cardiac disease
  6. Pregnancy/lactation
  7. Known allergy to trial drug
  8. Participation in another trial in last 3 months

7. Sample Size

For pilot clinical study: n = 60 (30 per arm), accounting for 15% dropout.
(For thesis-level protocol, include formal sample size calculation based on expected ETDRS change or BCVA improvement).

8. Randomization and Blinding

  • Computer-generated block randomization (1:1)
  • Allocation concealment using opaque sealed envelopes
  • Assessor blinding:
    • Ophthalmologist evaluating fundus/OCT blinded to group assignment
    • Statistician blinded to group coding

9. Interventions

Group A (Trial)

  • Vasadi Kwath 40 ml, orally, twice daily after food with equal lukewarm water, for 12 weeks
  • Plus standard diabetic care (ongoing physician-prescribed anti-diabetic therapy)

Group B (Control)

  • Standard diabetic care alone
    or placebo decoction + standard care (preferred for stronger design)

Common to Both Groups

  • Dietary/lifestyle counseling:
    • Diabetes diet
    • Sleep hygiene
    • Eye strain reduction
    • Mild exercise/yoga protocol standardized

10. Study Drug Details

  • Raw drug authentication by pharmacognosy department
  • GMP preparation and batch standardization:
    • Organoleptic profile
    • pH, specific gravity, microbial load, heavy metals, aflatoxins, pesticide residue
  • Dose rationale from classical text + OPD feasibility
  • Drug compliance monitored by return-bottle method and diary

11. Outcome Measures

Primary Outcomes

  1. Change in ETDRS DR severity level (baseline vs week 12)
  2. Change in BCVA (LogMAR) in study eye

Secondary Outcomes

  1. OCT central macular thickness
  2. Fundus lesion count/severity (microaneurysms, hemorrhages, exudates)
  3. Contrast sensitivity (if available)
  4. HbA1c, FBS, PPBS
  5. Timir symptom score (Ayurvedic composite scale):
    • Avyakta darshana (blurred vision)
    • Durdarsha/Alpadrishti
    • Floaters/visual distortion correlation
    • Eye fatigue, headache, burning (weighted score)
  6. NEI-VFQ-25 (quality of life)
  7. Safety labs: CBC, LFT, RFT

12. Visit Schedule

  • Screening (Day -7 to 0): Eligibility, consent, baseline labs
  • Baseline (Week 0): Randomization, BCVA, slit lamp, fundus photography, OCT, HbA1c, Ayurvedic assessment
  • Week 4: Clinical review, compliance, adverse events, FBS/PPBS
  • Week 8: Repeat visual + symptom assessment, safety review
  • Week 12 (End of treatment): Full ophthalmic + lab reassessment
  • Week 16 (Follow-up): Sustainability and delayed adverse event check

13. Safety Monitoring

  • Adverse event recording at each visit
  • Causality assessment (WHO-UMC scale)
  • Serious adverse event (SAE) reporting to IEC within 24 hours
  • Stopping rules:
    • Significant worsening requiring rescue retinal intervention
    • Severe drug intolerance
    • Participant withdrawal request

14. Data Management

  • Case Record Form (CRF)-based data capture
  • Unique participant IDs
  • Double data entry and periodic audit
  • Confidentiality maintained per GCP and local regulations

15. Statistical Analysis Plan

  • Analysis set: Intention-to-treat + per-protocol
  • Descriptive statistics: mean ± SD / median (IQR)
  • Between-group comparisons:
    • Independent t-test / Mann-Whitney U
    • Chi-square/Fisher exact for categorical variables
  • Within-group:
    • Paired t-test / Wilcoxon signed-rank
  • Repeated measures:
    • RM-ANOVA / mixed-effects model
  • Significance: p < 0.05
  • Missing data: multiple imputation or LOCF (pre-specified)

16. Ethical Considerations

  • IEC approval mandatory before recruitment
  • Trial registration (CTRI recommended)
  • Written informed consent in understandable language
  • Right to withdraw anytime
  • No denial of standard diabetic/ophthalmic care

17. Ayurveda-Specific Clinical Assessment Framework

Nidana Panchaka Documentation

  • Hetu: Madhura-ahara excess, sedentary habits, Divaswapna, Agnimandya
  • Purvarupa/Rupa: progressive drishti daurbalya, avyakta darshana
  • Samprapti: Madhumeha leading to Rasa-Rakta dushti, Srotorodha, Vata prakopa in Netra
  • Bheda avastha: staging correlated with NPDR grade

Additional Ayurveda Variables

  • Prakriti, Vikriti, Sara, Satmya
  • Dosha-Dushya sammurchana score
  • Agni and Aama status

18. Expected Outcomes

  • Slower progression of NPDR signs
  • Improvement/stabilization of visual acuity and symptoms of Timir
  • Better patient-reported visual functioning
  • Acceptable safety profile as adjuvant therapy

19. Limitations (to predefine)

  • Short intervention period for a chronic retinal disorder
  • Difficulty in complete blinding with decoction
  • Influence of glycemic control variability
  • Need for larger multicentric trial for confirmatory evidence

20. Suggested Thesis/Publication Format

  1. Introduction (Ayurveda + modern DR)
  2. Need for study
  3. Aims/objectives
  4. Materials and methods
  5. Observations/results
  6. Discussion (Ayurvedic and biomedical interpretation)
  7. Conclusion
  8. Limitations and future scope
If you want, I can also draft:
  1. Full synopsis format (PG/MS Ayurveda submission style),
  2. CRF templates (baseline + follow-up), and
  3. Ayurvedic Timir scoring proforma ready to print.
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