NCT00718094

Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild to Moderately Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Polyphenon E®	Oral capsules
DRUG	Placebo Oral Tablet	Oral tablet: placebo

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-10-01
• Completion: 2012-04-01
• First posted: 2008-07-18
• Last updated: 2017-12-14
• Results posted: 2017-12-14

Locations

1 site across 1 country: United States