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Efficacy of Vibrating Capsule in Patients With Chronic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508076
Recruitment Status : Unknown
Verified April 2018 by Zhuan Liao, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. defecation frequency [ Time Frame: 8 weeks ]
    the average weekly defecation frequency


Secondary Outcome Measures :
  1. Bristol Stool Chart [ Time Frame: 8 weeks ]
    Record the BSC of each defecation.

  2. first defecation [ Time Frame: 8 weeks ]
    The time of complete defecation after taking the capsule for the first time


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508076


Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China
Contact: Zhuan Liao, professor    13061921980    liaozhuan@smmu.edu.cn   
Sub-Investigator: Jin Yu         
Sponsors and Collaborators
Changhai Hospital
More Information
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Publications of Results:

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Responsible Party: Zhuan Liao, Deputy Director, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03508076    
Other Study ID Numbers: Vibrating Capsule
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share IPD when we finish this research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
Vibrating Capsule
Efficacy and Safety
Chronic Constipation
different vibrating modes
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive