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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild to Moderately Active Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00718094

Run by

University of Louisville

People needed

20

Starts

2008-03-01

Expected to finish

2012-04-01

Last updated by the study team

2017-12-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female with mildly to moderately active ulcerative colitis

You may not qualify if…

• Off prohibited medications for proscribed period of time
• Evidence of infectious colitis
• Labs outside of range
• Pregnancy or lactation

Where it is running

• University of Louisville Clinical Research Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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