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NCT00718094 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
A Phase 2 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00718094: Completed Phase 2 study, sponsored by University of Louisville.
NCT00718094 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00718094, a Phase 2 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Polyphenon E®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT00718094 record still lists
NCT00718094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT00718094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00718094 about?
NCT00718094 is a clinical study titled "Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis". 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...
What is the current status of trial NCT00718094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00718094?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Polyphenon E® (DRUG).
Who is sponsoring clinical trial NCT00718094?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00718094's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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