A randomized open labelled , parallel group study to evaluate the safety and efficacy of cutis capsule and cutis oil in Atopic Eczema
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the eczematic area and skin moisture level at end of study Â
研究概览
简要总结
The clinical study entitled “A randomized open labelled, Parallel group study to evaluate the safety and efficacy of Cutis Oil and Cutis capsule in Atopic Eczema†is carried out in the skin care unit of R.G.G.P.G. Ayu. College & Hospital, Paprola, Distt. Kangra (H.P.). This trial is sponsored by Vasu Research Centre, Vadodara. Two drugs - Cutis oil and Cutis capsule will be clinically tested in the patients of atopic eczema with EASI score 15. Total three group are made and 30 patients will be recruited in each group.
Group A - Cutis capsule group [Dose -1 capsule thrice a day after meal] Group B - Cutis oil group [Dose - topical application thrice a day on affected area] Group C - Cutis capsule and Cutis oil group [Dose - Topcial Application of oil and 1 tablet thrice a day]
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Non pregnant,non lactating females
- •Patient with atopic eczema according to Rajka and Hanifin criteria
- •Patient with EASI score 15 at time of screening.
排除标准
- •Pregnant,lactating mother
- •Patient with infected atopic eczema
- •Patient with severe systemic disorder
- •Patient with known hypersensitivity to excipients of drugs.
结局指标
主要结局
Change in the eczematic area and skin moisture level at end of study Â
时间窗: 0 day and 56th Day of the study
次要结局
- EASI score, SCORAD score,DLQI score at starting and at end of study(at 14 days,28 days,after 56 days)