Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00718094|
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mild to Moderately Active Ulcerative Colitis||Drug: Polyphenon E® Drug: Placebo Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||April 2012|
Experimental: Polyphenon E treatment
Polyphenon E® therapy was given for 56 days.
Drug: Polyphenon E®
Placebo Comparator: Placebo
Drug: Placebo Oral Tablet
Oral tablet: placebo
- Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718094
|United States, Kentucky|
|University of Louisville Clinical Research Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Gerald W Dryden, MD, MSPH||University of Louisville|