Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- Stool frequency
研究概览
简要总结
Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized Patients with acute watery diarrhea of both genders who are
- •Age: 03 months to 05 years
- •Present in first 24 hours of onset of disease.
排除标准
- •Parenteral Diarrhea
- •Chronic Diarrhea like Coeliac disease, Lactose intolerance
- •Mal-absorption Syndromes
- •Diarrhea related to food poisoning, dysentery as suggested by history
- •Severe dehydration patents who are vitally unstable.
- •Diarrhea associated with measles.
- •Persistent vomiting
- •Abdominal distention
- •Patients allergic to racecadotril
- •Patients managed before enrolled to study
研究组 & 干预措施
treatment group receiving (racecadotril+ORS+Zinc)
The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone
干预措施: Racecadotril (Drug)
the control group (receiving ORS + Zinc or standard treatment)
The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone
干预措施: Racecadotril (Drug)
结局指标
主要结局
Stool frequency
时间窗: 48 hours
Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups
次要结局
- Hospital Duration(48 Hours)
研究者
Aqsa Jabeen
Consultant
Liaquat National Hospital & Medical College
