Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

March 21, 2019 updated by: Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1108

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
    • Fujian
      • Xiamen, Fujian, China
        • Department of Gastroenterology, Zhongshan Hospital, Xiamen University
    • Guangzhou
      • Guangdong, Guangzhou, China
        • Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • 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, the Shanghai Tenth People's Hospital, Tongji University
    • Tianjin
      • Tianjin, Tianjin, China
        • Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Drug: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
PLACEBO_COMPARATOR: placebo
identical-appearing placebo supplements for 2-3 years
Drug: placebo
supplement of placebo two times per day for 2-3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rates of CRA
Time Frame: 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.
until the last patient reached the 2 years follow-up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fecal microflora
Time Frame: baseline, the 1st year and the 2nd year
Fecal microflora tests
baseline, the 1st year and the 2nd year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

December 29, 2018

Study Completion (ACTUAL)

December 29, 2018

Study Registration Dates

First Submitted

August 23, 2014

First Submitted That Met QC Criteria

August 23, 2014

First Posted (ESTIMATE)

August 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ2014BH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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