Skip to main content
OpenTrials
Completed

NCT Number: NCT00779493

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Carbohydrate Metabolism, Inborn Errors Colonic Diseases Colonic Diseases, Functional Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Constipation Diarrhea Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaiser Permanente

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curcumin

Dietary Supplement

curcumin 900mg twice daily by mouth

Other names: Swanson vitamins-curcumin

Placebo

Dietary Supplement

placebo capsule to simulate 900mg curcumin capsule

Other names: Swanson curcumin placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: CuTIBS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2008
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.