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

NCT00779493 | Completed Phase 4

• 1 other identifier: 4893
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; constipation; diarrhea; gas; bloating; abdominal pain; disturbance of defecation; irritable colon

Outcome Measures

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.

  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.

  end of observation and the end of treatment periods

Study Arms (2)

A

ACTIVE COMPARATOR

Curcumin 900mg twice daily by mouth

Dietary Supplement: curcumin

B

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

curcumin DIETARY_SUPPLEMENT

curcumin 900mg twice daily by mouth

Also known as: Swanson vitamins-curcumin

A

placebo DIETARY_SUPPLEMENT

placebo capsule to simulate 900mg curcumin capsule

Also known as: Swanson curcumin placebo

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation; Diarrhea; Mucopolysaccharidosis IV; Abdominal Pain

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• chris n conteas, md

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)