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

Phase 2

Completed

• Conditions: Mild to Moderately Active Ulcerative Colitis
• Interventions: Drug: Polyphenon E®; Drug: Placebo Oral Tablet

• Registration Number: NCT00718094
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Primary Completion: 2011-10
• Study Completion: 2012-04
• Results First Submitted: 2017-04-12
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-14
• Last Update Submitted: 2017-11-14
• Results First Posted: 2017-12-14
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyphenon E treatment	Polyphenon E®	Polyphenon E® therapy was given for 56 days.
Placebo	Placebo Oral Tablet	Oral Placebo

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.	day 56	This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.; Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; \>10: severe UC.

Trial Locations

Locations (1)

University of Louisville Clinical Research Center; 🇺🇸 Louisville, Kentucky, United States