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临床试验/CTRI/2019/11/022102
CTRI/2019/11/022102尚未招募2 期

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

Government siddha medical college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月22日最近更新:
适应症

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)

研究者

发起方
Government siddha medical college
申办方类型
Government medical college

研究点 (1)

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