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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779493
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: curcumin Dietary Supplement: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial
Study Start Date : November 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: A
Curcumin 900mg twice daily by mouth
Dietary Supplement: curcumin
curcumin 900mg twice daily by mouth
Other Name: Swanson vitamins-curcumin

Placebo Comparator: B
Placebo capsule to be made by Swanson Vitamins to simulate the capsule.
Dietary Supplement: placebo
placebo capsule to simulate 900mg curcumin capsule
Other Name: Swanson curcumin placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00779493

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United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
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Principal Investigator: chris n conteas, md Kaiser Permanente

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Responsible Party: Kaiser Permanente Identifier: NCT00779493    
Other Study ID Numbers: 4893
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Kaiser Permanente:
irritable bowel syndrome
abdominal pain
disturbance of defecation
irritable colon
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action