Critical Study of Tistraishaniya Adhyaya of Charaka Samhita w.s.r. to Bahiparimarjana Chikitsa and Comparative Clinical Efficacy of Mukhadushikahara Acne Patch and Mukhadushikahara Lepa along with Triphaladi Kashaya in the management of Mukhadushika (Acne Vulgaris)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relief in the Chief Complaints of Mukhadushika (Acne Vulgaris)-Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum) will be assessed. Number of lesions (papules/ pustules / nodular) & Area cover will be measured before and after treatment.
研究概览
简要总结
An open labelled, randomized, comparative, parallel, two arm clinical trial has been designed for comparison of efficacy of topical application of Mukhadushikahara Acne Patch and Mukhadushikahara Lepa along with Triphaladi Kashaya as internal medicine in the management of Mukhadushika (Acne Vulgaris) for 30 days. There will be two groups with sample size 50 in either group. Primary outcome will be relief in the Chief Complaints of Mukhadushika (Acne Vulgaris) viz. Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum). Secondary outcome will be Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation).
In group A - Mukhadushikahara Acne Patch (external) along with Triphaladi Kashaya as internal medicine will be given for 30 days.
In group B- Mukhadushikahara Lepa along with Triphaladi Kashaya as internal medicine will be given for 30 days.
Materials:
1. Patients of Mukhadushika (Acne vulgaris).
2. Trial drugs – Triphaladi Kashaya, Mukhadushikahara lepa, Mukhadushikahara Acne Patch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having classical signs and symptoms of Mukhadushika (Acne Vulgaris) on Face.
排除标准
- •The age of patient less than 18 years and more than 30 years.
- •Patients having Mukhadushika on other parts of body.
- •Known cases of any systemic diseases like Diabetes, Cardiac diseases, Renal disorder, Hypothyroidism etc.
- •or any viral infection.
- •Known cases of Carcinogenic condition of sebaceous gland.
结局指标
主要结局
Relief in the Chief Complaints of Mukhadushika (Acne Vulgaris)-Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum) will be assessed. Number of lesions (papules/ pustules / nodular) & Area cover will be measured before and after treatment.
时间窗: Baseline, 7th Day. 15th Day, 21st Day, 30th Day
Severity of Acne Vulgaris will be assessed using (IGAS scale) before and after treatment.
时间窗: Baseline, 7th Day. 15th Day, 21st Day, 30th Day
次要结局
- Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation) will be assessed.