CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,001 enrolled
Drug / intervention
Green tea extract of Camellia Sinensis +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01360320
NCT01360320Phase 2Completed
CompareCT.gov

Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

Martin-Luther-Universität Halle-Wittenberg·interventional·Posted May 25, 2011·Updated Sep 20, 2019

In Brief

A Phase 2 clinical trial evaluating Green tea extract of Camellia Sinensis and Green tea extract of Camellia Sinensis followed by placebo for Colorectal Serrated Adenomas and 3 related conditions. Completed, enrolled 1,001 participants across 21 sites.

Detailed Summary

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Serrated Adenomas, Colorectal Tubular Adenomas, Colorectal Villous Adenomas, Colorectal Tubulovillous Adenomas
CountriesGermany
CollaboratorsUniversity of Ulm, KKS Netzwerk, Deutsche Krebshilfe e.V., Bonn (Germany)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2019
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 15.1 years ago

Interventions

Green tea extract of Camellia Sinensisdietary

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG * Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks * 150mg EGCG two times daily (p.o.) over the course of three years. * Colonoscopy after 3 years

Green tea extract of Camellia Sinensis followed by placebodietary

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG * Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks * Placebo two times daily (p.o.) over the course of three years * Colonoscopy after 3 years