A Comparative Clinical Study on the efficacy of Safuf-i Baras and NB-UVB Phototherapy in Baras (Vitiligo)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reduction in Vitiligo Extent Tensity Index (VETI) Reduction in Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
Vitiligo is a skin condition characterized by the loss of melanocytes, leading to hypopigmentation and white patches. It can occur at any age but is most common in individuals during their 20s and 30s, affecting all ethnicities and genders. The prevalence of vitiligo ranges from 0.1 percent to 2 percent globally and can cause significant psychological distress, including anxiety and depression. The exact cause of vitiligo remains unclear, with various factors such as autoimmune reactions and oxidative stress implicated in melanocyte destruction. Treatment options include medical therapies like topical steroids and phototherapy, though these can have adverse effects. Unani medicine offers a range of treatments for vitiligo, with specific herbs and compounds noted for their potential efficacy. Historical figures like Ibn Sina have advocated for sunlight exposure as beneficial, aligning with modern treatments like Narrow Band UVB phototherapy. therefore, a clinical study is planned to investigate the effectiveness of the Unani formulation Safuf-i Baras combined with NB-UVB phototherapy for treating 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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of Non-Segmental Vitiligo,any gender and age group from 18-50years.
- •• Subjects with disease chronicity between 6 months to 2 years Subjects with less than or equal to 2 percent Body Surface Area (BSA) Subjects fulfilling the Vitiligo Extent Tensity Index (VETI) score up to a grade of tensity plus 3 Subjects who have not been taken any treatment in the past 2 weeks.
排除标准
- •Subjects with Mucosal and Universal variants NSV Subjects with Segmental Vitiligo/ Lip-Tip vitiligo Subjects with history of photosensitivity/photo-exaggerated dermatoses.
- •Pregnant and Lactating Women Patients suffering from systemic, metabolic and other autoimmune diseases.
- •Patients suffering from skin conditions like psoriasis, tinea, alopecia areata, halo nevus, pityriasis alba, melanoma and morphea.
结局指标
主要结局
Reduction in Vitiligo Extent Tensity Index (VETI) Reduction in Vitiligo Area Scoring Index (VASI)
时间窗: At baseline, 15th day, 30th day, 45th day and 60th day
次要结局
- Assessment of Quality of life in Vitiligo patients using DLQI (Dermatology Life Quality Index(At baseline and on last follow up (60th day))
研究者
Dr Meenu Doni
National Institute of Unani Medicine