Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in colon 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 Fig paste on functional constipation. The investigators measured colon transit time, frequency of defecation, defecation time, stool type, and abdominal discomfort.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 19 and 39 years,
- •diagnosis of functional constipation by ROME III criteria,
- •Colon transit time (CTT) ≥ 36 h,
- •subjects giving written informed consent
排除标准
- •allergic or hypersensitive response to any of the ingredients in the test products,
- •having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,
- •diagnosis of irritable bowel syndrome by ROME III criteria, etc,.
结局指标
主要结局
Changes in colon transit time
时间窗: 8 weeks
Colon transit time was measured in study baseline and visit 3(8 week). Colonic transit time was measured by the method of Metcalf et al,. Subjects ingested a once-daily series of three distinctive ColomarkTM capsules at the same time each day for three consecutive days. Each capsule contained twenty radioopaque makers of a ring shape. Subjects then received abdominal X-rays 24 after the ingestion of the final capsule. Abdominal X-rays through a Number of markers present was confirmed. The CTT was calculated as the sum of the markers detected on X-ray.
次要结局
- Changes in frequency of defecation(8 week)
- Changes in defecation time(8 week)
- Changes in stool type(8 week)
- Changes in abdominal discomfort(8 week)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital