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Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Primary Purpose

Colorectal Adenoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Berberine hydrochloride
placebo
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Adenoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Individuals aged 18-75 years
  • Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment
  • Individuals who are able to swallow pills
  • Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria
  • Individuals whose adenoma was not completely removed during previous colonoscopy
  • Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
  • Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D
  • Individuals with a history of subtotal/total gastrectomy or partial bowel resection
  • Individuals who are intolerant to another colonoscopy examination
  • Individuals who are hypersensitive or intolerant to the drugs
  • Individuals with severe heart, liver or kidney disease, or any cancer history
  • Individuals presenting severe constipation
  • Pregnant women, women during breast-feeding period, or women with expect pregnancy
  • Individuals with mental diseases who are not able to cooperate
  • Individuals who are involved in designing, planning or performing this trial

Sites / Locations

  • Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
  • Department of Gastroenterology, Zhongshan Hospital, Xiamen University
  • Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
  • Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
  • 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
  • Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
  • Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine hydrochloride

placebo

Arm Description

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

identical-appearing placebo supplements for 2-3 years

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2014
Last Updated
March 21, 2019
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02226185
Brief Title
Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence
Official Title
A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
December 29, 2018 (Actual)
Study Completion Date
December 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Berberine hydrochloride
Arm Type
Experimental
Arm Description
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
identical-appearing placebo supplements for 2-3 years
Intervention Type
Drug
Intervention Name(s)
Berberine hydrochloride
Intervention Description
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
supplement of placebo two times per day for 2-3 years
Primary Outcome Measure Information:
Title
Recurrence rates of CRA
Description
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
Secondary Outcome Measure Information:
Title
The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer
Description
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
Other Pre-specified Outcome Measures:
Title
Changes in fecal microflora
Description
Fecal microflora tests
Time Frame
baseline, the 1st year and the 2nd year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Individuals aged 18-75 years Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment Individuals who are able to swallow pills Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria Individuals whose adenoma was not completely removed during previous colonoscopy Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome) Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D Individuals with a history of subtotal/total gastrectomy or partial bowel resection Individuals who are intolerant to another colonoscopy examination Individuals who are hypersensitive or intolerant to the drugs Individuals with severe heart, liver or kidney disease, or any cancer history Individuals presenting severe constipation Pregnant women, women during breast-feeding period, or women with expect pregnancy Individuals with mental diseases who are not able to cooperate Individuals who are involved in designing, planning or performing this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Fang, M.D., Ph.D
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
City
Guangdong
State/Province
Guangzhou
Country
China
Facility Name
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
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
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31926918
Citation
Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY. Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):267-275. doi: 10.1016/S2468-1253(19)30409-1. Epub 2020 Jan 8.
Results Reference
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Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

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