Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Sponsor

Changhai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03508076

Collaborator

(none)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Device: Vibrating Capsule Device: Sham Capsule	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Actual Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Jun 30, 2018

Anticipated Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 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.	Device: Sham Capsule Capsules can't vibrate but look the same as Vibrating Capsule
Experimental: 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.	Device: Vibrating Capsule Patients in this group would be treated with Vibrating Capsule
Experimental: 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.	Device: Vibrating Capsule Patients in this group would be treated with Vibrating Capsule

Arm

Intervention/Treatment

Sham Comparator: 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.

Device: Sham Capsule

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

Experimental: 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.

Device: Vibrating Capsule

Patients in this group would be treated with Vibrating Capsule

Experimental: 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.

Device: Vibrating Capsule

Patients in this group would be treated with Vibrating Capsule

Outcome Measures

Primary Outcome Measures

defecation frequency [8 weeks]
the average weekly defecation frequency

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhuan Liao, Deputy Director, Changhai Hospital

ClinicalTrials.gov Identifier:

NCT03508076

Other Study ID Numbers:

Vibrating Capsule

First Posted:

Apr 25, 2018

Last Update Posted:

Apr 25, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhuan Liao, Deputy Director, Changhai Hospital

Vibrating Capsule

Efficacy and Safety

Chronic Constipation

different vibrating modes

Additional relevant MeSH terms:

Constipation

Study Results

No Results Posted as of Apr 25, 2018