A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Safūf Baraṣ compared with Methoxsalen in the Management of Baraṣ (Vitiligo)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 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
Baraá¹£ (Vitiligo) is marked by milky, white, depigmented.
It has a very prominent social and psychological impact
on the patients, with prevalence of 3-4% in India.
The available treatment in modern medicine, including
psoralens, corticosteroids, skin grafting and Monobenzyl
ether, have their own limitations numerous adverse
effects. In Unani medicine, various single and compound
drugs are effectively used in the treatment of vitiligo, but
these drugs need to be evaluated on scientific parameters.
Keeping this in view, the present clinical study has been
designed to evaluate the safety and efficacy of Safūf
Baraá¹£ in the Management of Baraá¹£ (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
- •The following patients will be included in the study: 1.Patients of any sex aged 18-60 years 2.Non-Segmental Vitiligo with Chronicity of 6 months to 2 years 3.Vitiligo involving more than 2% Body Surface Area (BSA) 4.Patients with less than 5 New Lesions in the last month 5.Patients with less than 15 lesions in the last 3 months 6.Patients who have not received systemic treatment within 4 weeks prior to study entry 7.Patients who have not received topical treatment within 2 weeks prior to study entry.
排除标准
- •The following patients will be excluded: 1.Patients aged less than 18 years or more than 60 years
- •Segmental Vitiligo/ Lip-Tip Vitiligo/ Universal Vitiligo/ Vitiligo with Leucotrichia
- •Significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction, and other Disorders requiring long-term treatment
- •Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
- •Pregnant or Lactating Women Patient 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 and 8 weeks
次要结局
- 1. Vitiligo Impact Scale-22 (VIS-((Assessment of Patient’s Quality of Life))
研究者
DR MOHD TARIQUE
DEPARTMENT OF MOALAJAT