Phase 2
Completed N=20
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Mild to Moderately Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT00718094 ↗
Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Dec 2017
Primary outcomePrimary: Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. — 10; 0 Participants — p=0.03
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. |
10; 0 | 0.03 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00718094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.