Lay Summary

Proposal No.  IBD-0191
Principal Investigator:  Mutsuhiro Ikuma, M.D., Ph.D. (Former Principal Investigator: Yukio Koide, M.D., Ph.D.)
Applicant Organization:  Hamamatsu University (Japan)
Project Title:  A randomized clinical trial of curcumin in the therapy of ulcerative colitis
Period of Award:  November 1, 2006 - April 30, 2009

Curcumin is a natural product contained in turmeric, a spice of curry. Curcumin is known to have a variety of pharmacological effects. Previously, we demonstrated that treatment with curcumin is able to prevent and improve experimental colitis in mice. Furthermore, we demonstrated the efficacy of curcumin in combination therapy with a commonly used drug in prevention of exacerbation of ulcerative colitis (UC) in a double-blind, controlled trial. Therefore, the aim of this clinical trial is to investigate the efficacy of curcumin without additional drugs in maintaining remission in UC in a randomized, double-blind fashion. Ten centers in Japan will enroll a total of 200 patients. Randomization will be performed by a clinical pharmacist and patients will be treated with either 4 g of curcumin or SASP/5-ASA for six months. Before and after treatment (one to three months after treatment and six months after treatment), the patients will be subjected to endoscopy combined with histological examination in biopsy specimens. Furthermore, the patients’ overall evaluation of symptoms is assessed at various time intervals.