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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,108
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
supplement of placebo two times per day for 2-3 years
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, Fujian, China
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, Guangzhou, China
Recurrence rates of CRA
The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.
Time frame: until the last patient reached the 2 years follow-up
The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer
The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention
Time frame: until the last patient reached the 2 years follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
Nanjing, Jiangsu, China
Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health
Shanghai, Shanghai Municipality, China
Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China