CTRI/2024/05/067246尚未招募2/3 期
A Single Arm Clinical Study to evaluate the efficacy of Lodhradi Churna in the management Of Atisara(Diarrhea) in children age 1 year to 12 year
Dr Pratik Kailas Auti1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年6月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction in frequency and quantity of stool
研究概览
简要总结
THIS IS SINGLE ARM CLINICAL STUDY IN WHICH LODHRADI CHURNA WILL BE PROVIDED TO 35 PATIENTS SHOWING SIGN AND SYMPTOMS OF ATISARA(DIARRHEA)THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE CHILDREN FROM 1YEAR TO 12 YEAR .THE MODE OF DRUG ADMINISTRATION WILL BE ORAL THRICE IN A DAY.FOLLOW UP WILL BE DONE ON 2ND AND 5TH DAY AND 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
- Na
- 盲法
- None
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 age group of 1 to 12 years will be selected irrespective of sex , socio-economic status and food habits.
- •Patient having atleast 2-3 symptoms of atisara(diarrhea) are as follows: Dravamalpravritti (Stool frequency) Malaswaroop (Stool appearance) Mutrapravritti (Urine output) Agnimandya(Loos of appetite) 3)Patient of acute diarrhea with mild degree of dehydration.
- •Parents willing for participation of their child in clinical trial and ready to give written assent.
- •In mild degree of dehydration, if patient need ORS,then it is given.
排除标准
- •Patients having any chronic or systemic illness.
- •Patients of moderate to severe dehydration and requiring hospital IPD management.
- •Patients suffering from the pravahika,Visuchika, Rakta Atisara.
- •Patient suffering from chronic diarrhea, persistent diarrhea, diarrhea due to acquired or congenital immune deficiency.
- •Patients having major problem in which required surgical correction like intussusceptions.
- •6.Patients having samavastha of disease.
结局指标
主要结局
Reduction in frequency and quantity of stool
时间窗: 0,2,5 Days
次要结局
- To study the adverse effect of Lodhradi churna(5 Days study with followup on 2nd and 5th day)
研究者
Dr Pratik Kailas Auti
Dr.D.Y.Patil College Of Ayurved Pimpri Pune Maharashtra 411018
研究点 (1)
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