Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Not Applicable

• Conditions: Chronic Constipation
• Interventions: Device: Vibrating Capsule; Device: Sham Capsule

• Registration Number: NCT03508076
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-23
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Adult patients aged form 18 to 80
• Clinical diagnosis of functional constipation
• Must be able to swallow vibrating capsule

Exclusion Criteria

• complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
• recent use of banned drugs.
• patients who are preparing for mri.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration Capsule of high level	Vibrating Capsule	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.
Vibration Capsule of low level	Vibrating Capsule	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.
Sham Capsule	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.

Primary Outcome Measures

Name	Time	Method
defecation frequency	8 weeks	the average weekly defecation frequency

Secondary Outcome Measures

Name	Time	Method
first defecation	8 weeks	The time of complete defecation after taking the capsule for the first time
Bristol Stool Chart	8 weeks	Record the BSC of each defecation.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China