NCT05345028已完成不适用
Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects
Azienda di Servizi alla Persona di Pavia1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Stoppage of diarrhea
研究概览
简要总结
Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to its an-ti-inflammatory, antispasmodic and antimicrobial activity.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of acute diarrhea of mild to moderate severity
排除标准
- •patients with long term diarrhea
- •iatrogenic diarrhea
- •symptoms of functional gut disease or severe inter-current diseases
- •severe diarrhea and dehydration requiring hospitalization and intravenous treatment
- •subjects with high temperature (> 38.5° C)
- •subjects treated by other anti-diarrheal and antibiotic drugs in the last 24 hours
- •severely malnourished subjects
- •pregnant women
结局指标
主要结局
Stoppage of diarrhea
时间窗: From baseline to 5 days
the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools
次要结局
- Self-assessed symptoms(After 5 days)
研究者
研究点 (1)
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