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A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
University of Louisville Clinical Research Center
Louisville, Kentucky, United States
Start Date
March 1, 2008
Primary Completion Date
October 1, 2011
Completion Date
April 1, 2012
Last Updated
December 14, 2017
20
ACTUAL participants
Polyphenon E®
DRUG
Placebo Oral Tablet
DRUG
Lead Sponsor
University of Louisville
Collaborators
Data Source & Attribution
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