At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Polyphenon E® and Placebo Oral Tablet for Mild to Moderately Active Ulcerative Colitis. Completed, enrolled 20 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Oral capsules
Oral tablet: placebo