Phase II An open single group non randomized study on "Venpulli"(Vitiligo) to evaluate the official siddha formulation "Athimathura chooranam(Int)& Ayilpattai pattru (Ext) in children of Both sex aging between 5-12 years attending OPD at Anna hospital
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- It is mainly assessed by reduction in VASI score
研究概览
简要总结
This is an phase II open single group non randomized study to evaluate the official siddha formulation Athimathura chooranam(Int)& Ayilpattai pattru (Ext) for venpulli (Vitiligo).The trial drug is given 0.5 - 1 gm twice a day for 48 days & Ayilpattai pattru externally for 48 days .Clinical trial conducted after conducting preclinical toxicity study. The trial drug Athimathura chooranam and Ayilpattai pattru is mentioned in Gunapadam Mooligai.During the trial ,study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •12 years Both Male and female children Hypo pigmented patches surrounded by hyper pigmented border present in any part of the body.
排除标准
- •Age below 4 years Albinism Piebaldsim Depigmented patches occurred after burns Hypopigmented patches starts firstly in lips,Genital area Juveline diabetes with vitiligo.
结局指标
主要结局
It is mainly assessed by reduction in VASI score
时间窗: 48 days
Photos of the patient before and after treatment for the clinical improvement
时间窗: 48 days
次要结局
- It is assessed by comparing the safety parameters before and after treatment(48 days)
