drugset / Trial / NCT00718094
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Phase 2
Completed
20 enrolled
University of Louisville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2008-03
- Primary completion
- 2011-10
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sinecatechins | Unknown | 400 mg | Oral |
| Subject | Sinecatechins | Unknown | 800 mg | Oral |