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临床试验/NCT02226185
NCT02226185已完成2 期

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

Shanghai Jiao Tong University School of Medicine7 个研究点 分布在 1 个国家目标入组 1,108 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
1,108
试验地点
7
主要终点
Recurrence rates of CRA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Berberine hydrochloride

Experimental

supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years

干预措施: Berberine hydrochloride (Drug)

placebo

Placebo Comparator

identical-appearing placebo supplements for 2-3 years

干预措施: placebo (Drug)

结局指标

主要结局

Recurrence rates of CRA

时间窗: 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.

次要结局

  • The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer(until the last patient reached the 2 years follow-up)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing-yuan Fang, MD, Ph. D

Director of Department of Gastroenterology

Shanghai Jiao Tong University School of Medicine

研究点 (7)

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