Phase II Non-randomized clinical study on Bala Karappan(Atopic Dermatitis) with the evaluation of siddha trial drug Yazhpanathennai(internal)and Nathaisoori ennai(external)in children.
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
- Reduction in EASI score(Eczema Area Severity Index)
研究概览
简要总结
This is a single Non-Randomized open clinical trial to study the safety and efficacy of siddha trial drug Yazhpanathennai (internal) is to be given 4 ml once a day for 10 days and External application of Nathaisoori Ennai on the affected area.Clinical trial conducted after conducting pre clinical study. The trial drug Yazhpanathennai has mentioned in Koshayi anuboga vaidya bramma ragasiyam,part-2 and External application of Nathaisoori Ennai has mentioned in Sarapendra vaithya muraigal. During the trial study related data will be recorded and documented. After the completion of the trial all data will be statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Itching Erythema Papules Vesicles Oozing Crusting Scaling Lichenification.
排除标准
- •Psoriasis Scabies Photo dermatitis Ichthyosis vulgaris Pityriasis alba.
结局指标
主要结局
Reduction in EASI score(Eczema Area Severity Index)
时间窗: 10 Days
Reduction in clinical symptoms like itching,papules,pustules,
时间窗: 10 Days
Oozing,scaling,lichenification
时间窗: 10 Days
次要结局
- It is assessed by comparing the safety parameters before and after treatment(10 Days)
研究者
Dr D Indrabala
Government Siddha Medical College Arumbakkam Chennai