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Trial record 3 of 193 for:    chronic constipation

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

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ClinicalTrials.gov Identifier: NCT03508076
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2017
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date April 25, 2018
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
defecation frequency [ Time Frame: 8 weeks ]
the average weekly defecation frequency
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • Bristol Stool Chart [ Time Frame: 8 weeks ]
    Record the BSC of each defecation.
  • first defecation [ Time Frame: 8 weeks ]
    The time of complete defecation after taking the capsule for the first time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Vibrating Capsule in Patients With Chronic Constipation
Official Title  ICMJE Efficacy of Vibrating Capsule in Patients With Chronic Constipation
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Constipation
Intervention  ICMJE
  • Device: Vibrating Capsule
    Patients in this group would be treated with Vibrating Capsule
  • Device: Sham Capsule
    Capsules can't vibrate but look the same as Vibrating Capsule
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sham 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.
    Intervention: Device: 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.
    Intervention: Device: Vibrating Capsule
Publications * Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2018)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2018
Estimated Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508076
Other Study ID Numbers  ICMJE Vibrating Capsule
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We may share IPD when we finish this research
Responsible Party Zhuan Liao, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP