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

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: curcumin; Dietary Supplement: placebo

• Registration Number: NCT00779493
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	curcumin	Curcumin 900mg twice daily by mouth
B	placebo	Placebo capsule to be made by Swanson Vitamins to simulate the capsule.

Primary Outcome Measures

Name	Time	Method
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.	at 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
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.	end of observation and the end of treatment periods

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Los Angeles, California, United States