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

Kaiser Permanente17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

curcuminDIETARY_SUPPLEMENT

curcumin 900mg twice daily by mouth

placeboDIETARY_SUPPLEMENT

placebo capsule to simulate 900mg curcumin capsule

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kaiser Permanente

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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