Pharmaceutico–analytical and Clinical study of Siddharthak gel in the management of Darunak with special reference to dandruff
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Improvement in signs and symptoms of Darunak (dandruff), including:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •18-50 years age group participants irrespective of sex, religion, socio-economic and marital status suffering from Darunak.
排除标准
- •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.
结局指标
主要结局
Improvement in signs and symptoms of Darunak (dandruff), including:
时间窗: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Kandu (itching)
时间窗: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Rukshata (dryness of scalp)
时间窗: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Twaksputana (scaling / flaking)
时间窗: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
Keshachyuti (hair fall)
时间窗: 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.
时间窗: Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment).
次要结局
- Trichoscopic Evaluation:(Reduction in dandruff grade using trichoscopic scoring (0–5 scale) assessing adherent scales and scalp erythema.)
研究者
Dr Mrunali Ajit Patil
Hon Shri Annasaheb Dange Ayurved Medical College, Post Graduate and Research Center, Ashta