NCT03333265

Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.

Detailed description

Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer. BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis.

Conditions

• Colorectal Adenomas

Interventions

Type	Name	Description
DRUG	100mg Berberine hydrochloride	patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months
DRUG	300mg Berberine hydrochloride	patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months
DRUG	Placebo Oral Tablet	patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-08-31
• Completion: 2021-06-01
• First posted: 2017-11-06
• Last updated: 2022-07-27

Locations

1 site across 1 country: China