CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Berberine Chloride +2 moredrug
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/NCT02365480
NCT02365480Phase 1Completed

Phase I Trial of Berberine in Subjects With Ulcerative Colitis

National Cancer Institute (NCI)·interventional·Posted Feb 19, 2015·Updated Aug 3, 2021

In Brief

A Phase 1 clinical trial evaluating Berberine Chloride, Laboratory Biomarker Analysis, and 1 other intervention for Ulcerative Colitis. Completed, enrolled 18 participants across 2 sites in 2 countries.

Detailed Summary

This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartJun 16, 2016
Primary CompletionFeb 16, 2018
Study CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.4 years ago

Interventions

Berberine Chloridedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Placebo Administrationother

Given PO