Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Phase 2

Completed

• Conditions: Colorectal Adenoma
• Interventions: Drug: Berberine hydrochloride; Drug: placebo

• Registration Number: NCT02226185
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 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.

Study Timeline

• Study First Submitted: 2014-08-23
• Study First Submitted QC: 2014-08-23
• Study First Posted: 2014-08-27
• Study Start: 2014-11
• Primary Completion: 2018-12-29
• Study Completion: 2018-12-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Berberine hydrochloride	Berberine hydrochloride	supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
placebo	placebo	identical-appearing placebo supplements for 2-3 years

Primary Outcome Measures

Name	Time	Method
Recurrence rates of CRA	until the last patient reached the 2 years follow-up	The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.

Secondary Outcome Measures

Name	Time	Method
The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer	until the last patient reached the 2 years follow-up	The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention

Trial Locations

Locations (7)

Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University; 🇨🇳 Shanghai, Shanghai, China

Department of Gastroenterology, Zhongshan Hospital, Xiamen University; 🇨🇳 Xiamen, Fujian, China

Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity; 🇨🇳 Guangdong, Guangzhou, China

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, China

Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China