CTRI/2017/08/009236招募中3 期
A randomised controlled study to evaluate the effectiveness of probiotics supplementation in the treatment of atopic dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 1. The mean difference in SCORAD in children with AD treated with conventional treatment plus probiotic supplementation versus conventional treatment alone at 0,12 and 24 weeks.
研究概览
简要总结
Recruitment of the patients have already been started for the study with proper written consent and it is under process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with atopic dermatitis diagnosed according to Hanifin and Rajka between aged 6 months to 12 years.
- •All children in the above mentioned age group with be eligible irrespective of the disease severity.
排除标准
- •Immunocompromised chilren
- •Children with severe hepatic, renal or other systemic disease
- •<6 months and >12 years of age.
结局指标
主要结局
1. The mean difference in SCORAD in children with AD treated with conventional treatment plus probiotic supplementation versus conventional treatment alone at 0,12 and 24 weeks.
时间窗: 0,12 and 24 weeks
2. Mean difference in the number of days of treatment required to achieve 90% reduction in SCORAD in children with AD treated with conventional treatment plus probiotic supplementation versus conventional treatment alone.
时间窗: 0,12 and 24 weeks
3. Number of children with AD who relapse after stoppage of treatment at 24 weeks
时间窗: 0,12 and 24 weeks
次要结局
- 1. To compare the IL-17 level in treatment vs control group at baseline and at 12 weeks(2. To compare the CDLQI and IDQOL at baseline and at 12 and 24 weeks)
研究者
研究点 (1)
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