Evaluation of the Efficacy of Shreerasadi Churna in Atisara (Diarrhea) in Children Age Group 1 to 12 Year.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- We will see the effect of interventional drug on the signs & symptoms of Atisara are expected to be reduced after the use of Shreerasadi Churna in childrens.
研究概览
简要总结
This is a single arm clinical study in which the medicine "Shreerasadi Churna” will be provided to 32 patients showing sign and symptoms of Atisara (Diarrhea). The age group taken for the study trial will be in between 1 years to 12 years. Shreerasadi Churna with Madhu will be given on 0 th day Thrice a Day for 5 days. Dose will be calculated by age formula. Follow up will be done on 2nd and 5th day and the total duration of case study will be 5 days. The final conclusion will be drawn on the basis of statistical methods.
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with 1 year to 12 year age group will be selected irrespective of sex, religion & socio economic class.
- •Patient of acute diarrhea with no signs of dehydration(according to WHO).
- •Atisara less than 5 days (less than 6 episodes/day).
- •ORS will given to the patient.
- •Patient having classical signs & symptoms of Atisara (Diarrhea).
排除标准
- •Patient suffering from persistent diarrhea, chronic diarrhea, pravahika ,persistent vomitting.
- •Diarrhea due to any immune deficiency like acquired or congenital.
- •Patients of some dehydration to severe dehydration (according to WHO)
- •Patients suffering from any chronic or systemic illness.
- •Atisara due to any food poisoning or iatrogenic origin.
结局指标
主要结局
We will see the effect of interventional drug on the signs & symptoms of Atisara are expected to be reduced after the use of Shreerasadi Churna in childrens.
时间窗: 5 days study with follow up on 2nd and 5th day | (0,2,5 days)
次要结局
- We will see reoccurrence and any side effect of interventional drug.