Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Duration of diarrheal episode
研究概览
简要总结
The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
详细描述
Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children.
Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute watery diarrhea
排除标准
- •Severe malnourishment
- •Severe dehydration
- •Systemic infections
- •Coinfections
研究组 & 干预措施
Racecadotril
intestinal antisecretory
干预措施: Racecadotril (Drug)
cornstach solution
Cornstarch powder diluted in distilled water
干预措施: Placebo (Other)
结局指标
主要结局
Duration of diarrheal episode
时间窗: five days
Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
次要结局
- Duration of hospitalization(five days)
- Weight of stool(five days)
- Frequency of stool per day(five days)
研究者
Giuseppe Grandy
Medical Chief of Nutrition Center
Centro Pediatrico Albina de Patino