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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
3 capsules (820 mg containig 500 mg curcumin each) twice daily.
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
Sheba Medical Center
Ramat Gan, Israel
The percentage of patients who achieve clinical remission compared between the two study arms.
The percentage of patients who achieve clinical remission compared between the two study arms at week 4 after induction of therapy. Clinical remission is defined as score of ≤2 in the Simple Clinical Colitis Activity Index (SCCAI) .
Time frame: 4 weeks
Time to response
Time to response (TTR) compared between study and control groups. Response is defined as remission or significant improvement. TTR is defined by number of days to achieve clinical response.
Time frame: 4 weeks
significant improvement
Percentage of patients that show significant improvement (drop of ≥3 points in SCCAI) compared between the two study arms at week 4 after induction of therapy.
Time frame: 4 weeks
serologic markers
Improvement in serologic parameters according to Seo index
Time frame: 4 weeks
Percentage of patient on corticosteroids or anti TNF treatment
Time frame: 4 weeks
improvement in endoscopic score
Improvement in endoscopic score compared to inclusion day (in subgroup of patients)
Time frame: 4 weeks
Improvement in IBD questionnaire (IBDQ).
Time frame: 4 weeks
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