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

Sheba Medical Center

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Curcumin; Drug: 5-aminosalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01320436

SHEBA-10-8356-AL-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Treatments arm

Active Comparator group

Description:

Patients allocated for this arm will receive 5ASA medication (as advised by their treating physician) + 3 capsules (total of 820 mg each,containing 500 mg curcumin ) curcumin twice daily after meals.

Treatment:

Dietary Supplement: Curcumin

Drug: 5-aminosalicylic acid

Control arm

Placebo Comparator group

Description:

Patients allocated to this arm will receive 5ASA medication (as advised by their treating physician) + 3 capsules (820gr each) of placebo twice a day after meals.

Treatment:

Drug: 5-aminosalicylic acid