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

Condition(s) targeted: Ulcerative Colitis

Intervention: Curcumin (Dietary Supplement); 5-aminosalicylic acid (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Alon Lang, MD, Principal Investigator, Affiliation: Sheba Medical Center
Nir Salomon, C.Ac, Principal Investigator, Affiliation: Sheba Medical Center

Overall contact:
Alon Lang, MD, Phone: 0543133413

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.

Official title: 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

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

Primary outcome: The percentage of patients who achieve clinical remission compared between the two study arms.

Secondary outcome: Time to response

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 medication dose for at least 4 weeks prior to inclusion

- Patient had hemoglobin of >10 g/dl.

- Able and willing to give written consent

Exclusion Criteria:

- Patient receiving immunomodulator therapy like azathioprine, 6-mercaptopurine or

cyclosporine.

- 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 CC therapy.

- Patients with proctitis.

Alon Lang, MD, Phone: 0543133413

Sheba Medical Center, Ramat Gan, Israel; Recruiting
Nir Salomon, C.Ac, Phone: 054-3010272, Email: nironsl@gmail.com
Alon Lang, MD, Principal Investigator
Nir Salomon, C.Ac, Sub-Investigator

Starting date: July 2011
Last updated: July 17, 2011