Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial (CuTIBS)
This study has been completed.
Sponsor:
Kaiser Permanente
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00779493
First received: October 22, 2008
Last updated: August 1, 2011
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | October 22, 2008 | ||||
| Last Updated Date | August 1, 2011 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Disease severity will be assessed using the irritable bowel severity score (IBSS) which utilizes a visual analog scale (VAS) (28). The primary outcome will be defined as at least 50% reduction in IBSS. [ Time Frame: at 6 months of treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00779493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in bowel movement frequency, consistency, frequency of as-needed medication use and bloating as measured by the VAS, and improvement SF-36 Quality of Life survey. [ Time Frame: end of observation and the end of treatment periods ] [ Designated as safety issue: No ] | ||||
| 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 | Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial | ||||
| Official Title ICMJE | Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial | ||||
| Brief Summary | Evidence exists to support low-grade inflammation as the inciting factor leading to visceral hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical literature,there is ample in vitro and in vivo evidence supporting turmeric and its derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a randomized, placebo-controlled, double blinded, parallel treatment study evaluating the effects of turmeric on the symptoms of irritable bowel syndrome. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Irritable Bowel Syndrome | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients from the hospitals and clinics of the Southern California Permanente Medical Group who conform to the Rome III criteria and
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00779493 | ||||
| Other Study ID Numbers ICMJE | 4893 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Chris Nicholas Conteas, MD, Kaiser Permanente-Southern California | ||||
| Study Sponsor ICMJE | Kaiser Permanente | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kaiser Permanente | ||||
| Verification Date | August 2011 | ||||
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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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