Clinical Trial: Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence:a Prospective, Double Blind, Randomized, Placebo-controlled, Multicenter Clinical Trial

Brief Summary: Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

Detailed Summary:

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention. [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The incidences of advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: August 23, 2014
Date Started: December 2014
Date Completion: December 2018
Last Updated: May 26, 2015
Last Verified: May 2015