CTRI/2025/03/081572尚未招募2/3 期
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of Dimad-E- Baras (Topical) Compared With Methoxasalen 1 Percent(Topical) In The Management Of Baras (Vitiligo)
National Research Institute of Unani Medicine for Skin Disorders1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change In Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
Baras(Vitiligo) is a skindisorder caused by the destruction of melanocytes, leading to depigmentedpatches. It affects 1%–2% of the global population and 3%–4% in India.Conventional treatments, such as medications or surgical procedures, often havelimited effectiveness, side effects, and high costs. Unani medicine offersaccessible and cost-effective alternatives. Dimad-e-Baras a polyherbal Unaniformulation, is proposed to stimulate regimentation in vitiligo patients. Aclinical trial is planned to scientifically evaluate its safety and efficacy,aiming to establish Dimad-e-Baras as a viable and affordable alternative toconventional vitiligo therapies*.*
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants having Non segmental vitiligo with Chronicity of 6 months to 3 years 2.Vitiligo involving more than 2 percent Body Surface Area (BSA) 3.Participants with less than 5 new lesions in the last month 4.Participants with less than 15 lesions in the last 3 months 5.Participants who have not taken systemic and tropical treatment in the last 4 week.
排除标准
- •1.Participants aged less than 18 years or more than 60 years 2.Participants with Segmental vitiligo/acrofacial vitiligo/mucosal vitiligo and vitiligo universalis 3.Participants with history of any other skin disorders and inflammatory condition of the skin 4.Pregnant or Lactating Women 5.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 6.Known cases of Diabetes Mellitus 7.Known cases of Immunocompromised states.
结局指标
主要结局
Change In Vitiligo Area Scoring Index (VASI)
时间窗: 0,2,4 and 8 weeks
次要结局
- 1.Improvement in Patient’s Global Assessment (PGA) on VAS for Vitiligo(2.Improvement in Investigator’s Global Assessment (IGA) for Vitiligo)
研究者
研究点 (1)
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