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

NCT ID: NCT00779493

Last Updated: 2015-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Curcumin 900mg twice daily by mouth

Group Type ACTIVE_COMPARATOR

curcumin

Intervention Type DIETARY_SUPPLEMENT

curcumin 900mg twice daily by mouth

B

Placebo capsule to be made by Swanson Vitamins to simulate the capsule.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo capsule to simulate 900mg curcumin capsule

Interventions

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curcumin

curcumin 900mg twice daily by mouth

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo capsule to simulate 900mg curcumin capsule

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Swanson vitamins-curcumin Swanson curcumin placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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chris n conteas, md

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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4893

Identifier Type: -

Identifier Source: org_study_id

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