Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Curcumin (Dietary Supplement); 5-aminosalicylic acid (Drug)
Phase: Phase 3
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
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.
- Diagnosis of UC as confirmed by endoscopic or histologic criteria as established by
- 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
- Patient receiving immunomodulator therapy like azathioprine, 6-mercaptopurine or
- 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.
Locations and Contacts
Sheba Medical Center, Ramat Gan, Israel
Starting date: July 2011
Last updated: November 2, 2014