NCT02226185

Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,108 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Colorectal Adenoma

Interventions

Type	Name	Description
DRUG	Berberine hydrochloride	supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
DRUG	placebo	supplement of placebo two times per day for 2-3 years

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-12-29
• Completion: 2018-12-29
• First posted: 2014-08-27
• Last updated: 2019-03-26

Locations

7 sites across 1 country: China