Efficacy of Vibrating Capsule in Patients With Chronic Constipation
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedApril 25, 2018
April 1, 2018
1.4 years
April 23, 2017
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
defecation frequency
the average weekly defecation frequency
8 weeks
Secondary Outcomes (2)
Bristol Stool Chart
8 weeks
first defecation
8 weeks
Study Arms (3)
Sham Capsule
SHAM COMPARATORPatients 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.
Vibration Capsule of low level
EXPERIMENTALPatients 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.
Vibration Capsule of high level
EXPERIMENTALPatients 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.
Interventions
Patients in this group would be treated with Vibrating Capsule
Eligibility Criteria
You may qualify if:
- Adult patients aged form 18 to 80
- Clinical diagnosis of functional constipation
- Must be able to swallow vibrating capsule
You may not qualify if:
- complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
- recent use of banned drugs.
- patients who are preparing for mri.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 28588191RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
April 23, 2017
First Posted
April 25, 2018
Study Start
February 1, 2017
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
April 25, 2018
Record last verified: 2018-04