Documenting the Efficacy of Guava (Psidium guajava) leaf decoction for treating patients with Diarrhoea.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1.Control of diarrhoea
研究概览
简要总结
The study will undertake a proof of concept clinical trial with guava leaf decoction to confirm its antidiarrhoeal activity previously demonstrated using in vitro and in vivo assays.
This study will not only provide evidence for efficacy but also provide the information regarding doses to be used in the formaulation and the sample size for future multi centric double blind clinical trials,Additionally the evidence generated from this trial is crucial to generate confidence which will allow Foundation of Medical research to access funding for development for a formulation and to collaborate with industry for its manufacture and distribution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults age 18-65 years presenting with the acute Infectious diarrhoea of more than 2 days duration.
- •Patient with uncomplicated hypertension and diabetes.
排除标准
- •Adults below 18 years and above 65 years of age will be excluded.
- •Pregnant and lactating women Non Ambulatory patient Patient with antibiotic related diarrhoea Patient with diarrhoea suspected to be caused by food related allergy.
- •Patient Currently on anti diarrhoeal treatment or severly dehydrated.
- •Patient who have taken laxatives upto 72 hours prior to reporting.
- •Patient with any non gastro intestinal complications including previous G.I Surger.
- •Patient with non chronic medical problem related to liver,kidney and heart with abnormal value based on investigations done.
结局指标
主要结局
1.Control of diarrhoea
时间窗: 18 months
3.The appropriate dose of decoction to be used for treatment of patient with infectious diarrhoea
时间窗: 18 months
2. The Efficacy of the guava decotion in the treatment of infectious diarrhoea ,compared to standard allopathic treatment.
时间窗: 18 months
次要结局
- 1. Side Effects of the guava leaf decoction(2.The order in which the symptoms get resolved would give an indication of the possible efficacy of the decoction for the treatment of physiological diarrhoea.)