NCT01320436

Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis

Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in patients. The current standard treatment for mild to moderate UC (MTMUC) includes 5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients continue to experience disease symptoms and flare-ups. These patients require higher dosages of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy which comprises higher risk of hazardous side effects. Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. In humans, a controlled study using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in maintaining remission in MTMUC patients . A small, preliminary open label study has also shown efficacy in reducing disease symptoms and inflammatory markers in this group of patients . This data provides bases for investigating an integrative approach to optimize the current standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA medication and curcumin could benefit this subgroup of patients and reduce morbidity and perhaps need for escalating pharmacological intervention.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Curcumin	3 capsules (820 mg containig 500 mg curcumin each) twice daily.
DRUG	5-aminosalicylic acid	The dosage of 5ASA medication will be the maximum dosage given in this group of patients according to clinical guidelines (4gr' per os + topical 1gr mesalamine

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2011-03-22
• Last updated: 2016-02-12

Locations

1 site across 1 country: Israel