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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
A reduction in the Disease Activity Index of >3, or clinical remission.
Gerald W Dryden, MD, MSPH
University of Louisville
United States: Food and Drug Administration
|University of Louisville Clinical Research Center||Louisville, Kentucky 40202|