NCT02280759已完成1 期
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Duration of diarrhea
研究概览
简要总结
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children < 5 years old
- •diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
- •inform consent sign
排除标准
- •regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
- •underlying gastrointestinal tract disorder presenting with diarrhea
- •breastfeeding >50%
- •malnutrition (weight/high <3pc)
研究组 & 干预措施
Gelatin Tannate
Active Comparator
Gelatin Tannate:
4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.
干预措施: Gelatin Tannate (Drug)
Placebo
Placebo Comparator
Placebo consists of an identical formulation, except active substance.
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of diarrhea
时间窗: 7 days
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours
次要结局
- Need of intravenous rehydration due to diarrhea(7 days)
- Need of hospitalization in outpatients(7 days)
- Vomiting(How many times for 7days)
- Weight gain(7 days)
- Diarrhea recurrence(7 days)
- Frequency of watery stools(7 days)
- Adverse effects(7 days)
- Severity of diarrhea due to modified Vesikari score(7 days)
研究者
研究点 (1)
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