Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Colonic Transit Time
研究概览
简要总结
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of Constipation. The investigators measured Improvement of Constipation parameters , including Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool amounts per defecation, and monitored their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-40 years old
- •Subject who have functional constipation by ROME IIII criteria
- •Subject who have over 36 hour colonic transit time
- •Able to give informed consent
排除标准
- •Subject who have Irritable bowel syndrome by ROME IIII criteria
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
结局指标
主要结局
Changes in Colonic Transit Time
时间窗: 8 weeks
Colonic Transit Time was measured in study visit 1(0 week) and visit 3(8 week).
Changes in number of bowel movement
时间窗: 8 weeks
Number of bowel movement was measured in study visit 1(0 week) and visit 3(8 week).
Changes in defecation time
时间窗: 8 weeks
Defecation time was measured in study visit 1(0 week) and visit 3(8 week).
次要结局
- Changes in stool type(8 weeks)
- Changes in stool color(8 weeks)
- Changes in stool amounts per defecation(8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital