Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diarrheal episode
研究概览
简要总结
In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.
详细描述
Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group for six months - 5 years.
- •No or mild to moderate dehydration.
- •Alert patient (to tolerate oral intake since the drug is only available in oral form).
排除标准
- •Patients with severe dehydration (inability to drink because of drowsiness).
- •Patients with any serious concomitant illness that needs antibiotic treatment.
- •If severe adverse events occur at any time.
- •Chronic diarrhea.
研究组 & 干预措施
children received ORS and racecadotril as treatment
25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days)
干预措施: Racecadotril (Drug)
children received ORS alone as treatment
25 children received ORS alone for treatment as a control group
干预措施: Racecadotril (Drug)
结局指标
主要结局
Diarrheal episode
时间窗: 1-3 months
number
次要结局
未报告次要终点
研究者
Mariam Roshdy Elkhayat
Lecturer
Assiut University