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

NCT ID: NCT01320436

Last Updated: 2016-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatments arm

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.

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

3 capsules (820 mg containig 500 mg curcumin each) twice daily.

5-aminosalicylic acid

Intervention Type: DRUG

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

Control arm

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.

Group Type: PLACEBO_COMPARATOR

5-aminosalicylic acid

Intervention Type: DRUG

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

Interventions

Curcumin

3 capsules (820 mg containig 500 mg curcumin each) twice daily.

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Other Intervention Names

Pentasa, Asacol, Rafasal, Mesalamine.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Alon Lang

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alon Lang, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Nir Salomon, C.Ac

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

References

Lang A, Salomon N, Wu JC, Kopylov U, Lahat A, Har-Noy O, Ching JY, Cheong PK, Avidan B, Gamus D, Kaimakliotis I, Eliakim R, Ng SC, Ben-Horin S. Curcumin in Combination With Mesalamine Induces Remission in Patients With Mild-to-Moderate Ulcerative Colitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1444-9.e1. doi: 10.1016/j.cgh.2015.02.019. Epub 2015 Feb 24.

Reference Type: DERIVED

PMID: 25724700 (View on PubMed)

Other Identifiers

SHEBA-10-8356-AL-CTIL

Identifier Type: -

Identifier Source: org_study_id