Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type SHAM_COMPARATOR

Sham Capsule

Intervention Type DEVICE

Capsules can't vibrate but look the same as Vibrating Capsule

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.

Group Type EXPERIMENTAL

Vibrating Capsule

Intervention Type DEVICE

Patients in this group would be treated with Vibrating Capsule

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.

Group Type EXPERIMENTAL

Vibrating Capsule

Intervention Type DEVICE

Patients in this group would be treated with Vibrating Capsule

Interventions

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Vibrating Capsule

Patients in this group would be treated with Vibrating Capsule

Intervention Type DEVICE

Sham Capsule

Capsules can't vibrate but look the same as Vibrating Capsule

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No