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A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

Colorectal Adenomas Clinical Trial

Official title:
A Randomized Trial of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

Clinical Trial Summary

Experimental studies in animals and observational studies in humans suggest that fusobacterium nucleatum is associates with stages of colorectal neoplasia development, and Berberine Hydrochloride could rescue Fusobacterium nucleatum-induced colorectal tumorigenesis by modulating the tumor microenvironment. Whether regular Berberine Hydrochloride use may decrease the risk of colorectal adenomas, the precursors to most colorectal cancers is worth to further study.

Clinical Trial Description

The prevalence of colorectal adenomas is high in our country, as is the incidence of colorectal cancer. It is well-known that colorectal adenomas are the precursor of colorectal cancer and that removing them will prevent colorectal cancer. Because most colorectal cancers arise from benign adenomas, adenomas have been used as surrogate end points in prevention trials. Berberine hydrochloride, which is an alkaloid extracted from Rhizoma coptidis, has been traditionally used in Chinese medicine to treat gastrointestinal infections, due to its antimicrobial properties. Previous clinical research and animal studies have demonstrated the anti-tumor action of Berberine hydrochloride. Persons with a history of colorectal cancer might constitute a group at higher risk for adenomas and thus be particularly suitable for a study of the chemopreventive effects of Berberine hydrochloride. Here, a randomized, double-blind, placebo-controlled trial was designed to determine whether the daily use of 300 mg of berberine hydrochloride could decreases the occurrence of new colorectal adenomas among patients with a history of colorectal cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03281096
Study type Interventional
Source Xijing Hospital of Digestive Diseases
Contact
Status Completed
Phase Phase 2/Phase 3
Start date August 29, 2017
Completion date March 1, 2021
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