Acupuncture for Patients With Diarrhea-predominant IBS: a Randomized Controlled Trial
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2011 | ||||
| Last Updated Date | May 10, 2013 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Average daily stool frequency [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: No ] Average daily stool frequency, change from baseline in 4 weeks |
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| Original Primary Outcome Measures ICMJE |
The number of months patients were classified an adequate overall relief [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: No ] The time frame-4th week after inclusion is the end of the treatment. |
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| Change History | Complete list of historical versions of study NCT01350570 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acupuncture for Patients With Diarrhea-predominant IBS: a Randomized Controlled Trial | ||||
| Official Title ICMJE | Acupuncture for Functional Bowel Disease | ||||
| Brief Summary | This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control. |
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| Detailed Description | Outcome measurements: The number of months patients were classified as adequate overall relief responder during the double-blind treatment period; The bristol stool scale; SF-36 evaluation |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 472 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01350570 | ||||
| Other Study ID Numbers ICMJE | 2011CB5200-Fd | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chengdu University of Traditional Chinese Medicine | ||||
| Study Sponsor ICMJE | Chengdu University of Traditional Chinese Medicine | ||||
| Collaborators ICMJE | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | ||||
| Investigators ICMJE |
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| Information Provided By | Chengdu University of Traditional Chinese Medicine | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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