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Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial (CuTIBS)

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00779493
First received: October 22, 2008
Last updated: August 1, 2011
Last verified: August 2011

October 22, 2008
August 1, 2011
November 2008
June 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00779493 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial
Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Dietary Supplement: curcumin
    curcumin 900mg twice daily by mouth
    Other Name: Swanson vitamins-curcumin
  • Dietary Supplement: placebo
    placebo capsule to simulate 900mg curcumin capsule
    Other Name: Swanson curcumin placebo
  • Active Comparator: A
    Curcumin 900mg twice daily by mouth
    Intervention: Dietary Supplement: curcumin
  • Placebo Comparator: B
    Placebo capsule to be made by Swanson Vitamins to simulate the capsule.
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients from the hospitals and clinics of the Southern California Permanente Medical Group who conform to the Rome III criteria and

  • Age 18 years and above,
  • Male or female,
  • Able to give consent and follow the treatment plan and be able to answer surveys.
  • Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.

Exclusion Criteria:

  • Any of the following: diabetes, HIV disease, use of anticoagulants or antiplatelet medication, abnormal coagulation or thrombocytopenia, biliary obstruction, inflammatory bowel, symptomatic gallstones, celiac disease, ongoing use of medications known to cause or exacerbate symptoms of IBS and chronic, daily users of IBS medications.
  • Use of scheduled IBS medications for 4 weeks prior to and during the treatment period.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00779493
4893
No
Chris Nicholas Conteas, MD, Kaiser Permanente-Southern California
Kaiser Permanente
Not Provided
Principal Investigator: chris n conteas, md Kaiser Permanente
Kaiser Permanente
August 2011

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