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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Aminosalicylic Acid; Curcumin; Mesalamine

Criteria

Inclusion Criteria:

• Diagnosis of UC as confirmed by endoscopic or histologic criteria as established by RomeIII

• Disease activity score of >5 and ≤13 according to the Simple clinical colitis activity index (SCCAI)

• Patient on stable 5 ASA medication dose for at least 4 weeks prior to inclusion

• Patients who receive immunosuppressant or biological therapy (azathioprine, 6-mercaptopurine, infliximab or methotrexate) must be on stable dose for at least 3 months prior to inclusion

• Patients who receive topical therapy (5ASA or steroidal), must be on stable dose for a least 2 weeks prior to inclusion

• Patient had hemoglobin of >10 g/dl.

• Able and willing to give written consent

Exclusion Criteria:

• Patient with renal or liver disease, sever cardiovascular disease, chronic pancreatitis, diabetes mellitus or gallstone.

• Patient with laboratory abnormalities indicating anemia (hemoglobin <10), leucopenia, thrombocytopenia, abnormal coagulation.

• Patient with infection, sepsis or pneumonia.

• Pregnant or nursing women.

• Unable or unwilling to receive CURCUMIN therapy.