NCT00732732终止不适用
A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Frequency of stools per day.
研究概览
简要总结
Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea.
The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea.
Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study).
Two hundred patients will be enrolled in 24 months.
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
- 5 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital.
- •Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject
- •The consistency of the stool is such that it takes the shape of the container into which it is put in.
- •Duration of symptoms should be less than 14 days.
排除标准
- •Children with bloody diarrhea
- •Children with lethargy, fever or other signs of septicemia
- •Children with shock.
- •Children unable to take medications orally.
- •Children with impaired consciousness.
- •Children whose parents refuse permission to be included in the study.
- •Children who are not usual residents of the area and will not be available for follow up.
- •Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc.
结局指标
主要结局
Frequency of stools per day.
时间窗: Daily for 10 days
次要结局
- Change in the consistency of stool.(Daily for 10 days)
研究者
研究点 (2)
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