Efficacy of Vibrating Capsule in Patients With Chronic Constipation
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- defecation frequency
研究概览
简要总结
Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and Colon transmission experiment were compared with the constipated patients before treatment.
详细描述
Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem.
Investigators have developed a vibration capsule that can be adjusted in different modes.
Preliminary animal experiments showed that the capsule was safe and increased the number of defecation.
This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.
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
- Double (Participant, Investigator)
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
- •Adult patients aged form 18 to 80
- •Clinical diagnosis of functional constipation
- •Must be able to swallow vibrating capsule
排除标准
- •complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
- •recent use of banned drugs.
- •patients who are preparing for mri.
研究组 & 干预措施
Sham Capsule
Patients swallowed 1 sham Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
干预措施: Sham Capsule (Device)
Vibration Capsule of low level
Patients swallowed 1 low level vibration Capsule Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
干预措施: Vibrating Capsule (Device)
Vibration Capsule of high level
Patients swallowed 1 high level vibration Capsule Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
干预措施: Vibrating Capsule (Device)
结局指标
主要结局
defecation frequency
时间窗: 8 weeks
the average weekly defecation frequency
次要结局
- first defecation(8 weeks)
- Bristol Stool Chart(8 weeks)
研究者
Zhuan Liao
Deputy Director
Changhai Hospital