CTRI/2025/11/097946尚未招募2 期
A Randomized,Parallel Group,Open Label,Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Polyherbal Unani Formulation Compared With Methoxsalen In The Management Of Baras (Vitiligo)
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
| Baras (Vitiligo) is an acquired pigmentary disorder marked |
| by asymptomatic depigmented patches due to melanocyte loss. It affects 0.5–2% |
| of the population, with onset often before age 20, equally in both sexes. The |
| condition leads to psychological distress, low self-esteem, and impaired |
| quality of life. While several hypotheses—autoimmune, neural, and |
| biochemical—attempt to explain its pathogenesis, no single theory suffices. |
| Current treatments like psoralens and corticosteroids have limited efficacy |
| and notable side effects. Unani medicine offers safer, affordable alternatives. |
| Keeping in view the magnitude of |
| the problem a clinical study has been planned titled , A Randomized, |
| Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of |
| a PolyherbalUnani Formulation compared with Methoxsalen in the |
| Management of Baras (Vitiligo). |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 of any sex aged 18-60 years 2.Non-Segmental Vitiligo with Chronicity of 6 months to 3 years 3.Participants with less than 5 new lesions in the last 1 month 4.Participants with less than 15 lesions in the last 3 months 5.Participants who have not taken systemic treatment within 4 weeks prior to study entry 6.Participants who have not taken topical treatment within 2 weeks prior to study entry.
排除标准
- •1.Participants aged less than 18 years or more than 60 years 2.Segmental Vitiligo/ Lip-Tip vitiligo/ Universal Vitiligo/ vitiligo with Leucotrichia 3.History of photosensitivity/ photo exaggerated dermatoses and Connective Tissue Diseases 4.Pregnant or Lactating Women 5.Significant Cardiovascular/ Pulmonary/ Hepato-renal Dysfunction, or any chronic disease requiring long-term treatment 6.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal) 7.Participants not willing to attend treatment schedule regularly.
结局指标
主要结局
Reduction in Vitiligo Area Scoring Index (VASI)
时间窗: 0,2,4,6, 8th week
次要结局
- 1.Vitiligo Impact Scale (VIS)-22((Assessment of Patient’s Quality of Life))
研究者
DR AFREEN SADIQUE SHAIKH
National Research Institute Of Unani Medicine For Skin Disorders (NRIUMSD), Hyderabad
研究点 (1)
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