Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- IBS Global Improvement Scale
研究概览
简要总结
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
详细描述
Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable bowel syndrome.
排除标准
- •Any signs of organic bowel disease such as rectal bleeding.
- •No other major illnesses.
结局指标
主要结局
IBS Global Improvement Scale
时间窗: 3 weeks
次要结局
- IBS Adequate Relief(3 weeks)
- IBS quality of life (QoL)(3 weeks)
- IBS Symptom Severity Scale(3 weeks)