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

Irritable Bowel Syndrome Clinical Trial

— CuTIBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779493
• Other study ID #: 4893
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: March 10, 2015
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• curcumin
curcumin 900mg twice daily by mouth
• placebo
placebo capsule to simulate 900mg curcumin capsule

Locations

Country	Name	City	State
United States	Kaiser Permanente	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No