Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Naval Military Medical University

Status: Unknown

Conditions: Chronic Constipation

Treatments: Device: Vibrating Capsule; Device: Sham Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03508076

Vibrating Capsule

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 3 patient groups

Sham Capsule

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Capsule

Vibration Capsule of low level

Experimental group

Description:

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.

Treatment:

Device: Vibrating Capsule

Vibration Capsule of high level

Experimental group

Description:

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.

Treatment:

Device: Vibrating Capsule