Clinical trial NCT01320436: Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Curcumin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The percentage of patients who achieve clinical remission compared between the two study arms.
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to response
timeFrame: 4 weeks
measure: significant improvement
timeFrame: 4 weeks
measure: serologic markers
timeFrame: 4 weeks
measure: Percentage of patient on corticosteroids or anti TNF treatment
timeFrame: 4 weeks
measure: improvement in endoscopic score
timeFrame: 4 weeks
measure: Improvement in IBD questionnaire (IBDQ).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Alon Lang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Nir Salomon, C.Ac
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.