Pharmaceutico–analytical and Clinical study of Siddharthak gel in the management of Darunak with special reference to dandruff
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Improvement in signs and symptoms of Darunak (dandruff), including:
Study Overview
Brief Summary
This study is designed to evaluate the pharmaceutico analytical and clinical efficacy of Siddharthak Gel, a novel polyherbal topical formulation, in the management of Darunak with special reference to dandruff. Siddharthak Gel is prepared from Siddharthak Choorna containing Musta, Madanphala, Triphala, Karanja, Aaragvadh, Indrayava, Darvi, and Saptaparna in a carbopol based gel form. The objective is to assess its effect on cardinal symptoms such as Kandu, Rukshata, Twaksputana, and Keshachyuti, as well as to observe improvement through trichoscopic evaluation. The trial is a single arm, open label, prospective clinical study involving 140 participants aged 18 to 50 years. The formulation will be applied topically on the scalp, 10 g per dose, once on alternate days for 14 days. The study aims to establish the efficacy and safety of Siddharthak Gel as a standardized and patient friendly topical formulation for dandruff management based on Ayurvedic principles of Darunak Chikitsa.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18-50 years age group participants irrespective of sex, religion, socio-economic and marital status suffering from Darunak.
Exclusion Criteria
- •Participants suffering from severe seborrheic dermatitis, psoriasis of scalp, eczema of scalp, participants of immune compromised conditions, known case of Diabetes mellitus and suffering from systemic infections will be excluded from the study.
- •Participants taking other treatment modalities will also be excluded from study.
Outcomes
Primary Outcomes
Improvement in signs and symptoms of Darunak (dandruff), including:
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Kandu (itching)
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Rukshata (dryness of scalp)
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Twaksputana (scaling / flaking)
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Keshachyuti (hair fall)
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Each parameter graded on 0–3 scale (0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe). Mean percentage reduction in total symptom score will be evaluated.
Time Frame: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Secondary Outcomes
- Trichoscopic Evaluation:(Reduction in dandruff grade using trichoscopic scoring (0–5 scale) assessing adherent scales and scalp erythema.)
Investigators
Dr Mrunali Ajit Patil
Hon Shri Annasaheb Dange Ayurved Medical College, Post Graduate and Research Center, Ashta