An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation karappan kudineer chooranam (internal ) and karappan ennai (external )for the treatment of sattai karappan
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
- the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal)karappan ennai (external)on Sattai karappan
研究概览
简要总结
The study is prospective open labeled non randomized phase 2 an open clinical study to evaluate the clinical efficacy of siddha sasthric formulation Karappan kudineer chooranam(internal) Karappan ennai (external) 3-7 years 30ml,7-12years 60ml,twice a day (morning and evening)internally and Oil-externally for 21 days in 40 patients during the trail period of 13months that will be conducted in government siddha medical college and hospital palayamkottai Tamil nadu The primary outcome will be the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal) karappan ennai(external)on Sattai karappan The secondary outcome will be the evaluation of siddha diagnostic parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with appropriate symptoms of intense itching erythema papules papulovesicles crusted lesion all over the body ulceration exudation constipation.
排除标准
- •children above 12 years scabies psoriasis secondary bacterial infection nummular dermatitis contact dermatitis seborric dermatitis furunculosis photo dermatitis neuro dermatitis.
结局指标
主要结局
the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal)karappan ennai (external)on Sattai karappan
时间窗: 21 days
次要结局
- Evaluation of siddha diagnostic parameters(21 days)