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Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

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ClinicalTrials.gov Identifier: NCT02226185
Recruitment Status : Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jing-yuan Fang, MD, Ph. D, 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.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Drug: Berberine hydrochloride Drug: placebo Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 1061 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence:a Prospective, Double Blind, Randomized, Placebo-controlled, Multicenter Clinical Trial
Actual Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2 years
Drug: Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2 years
Placebo Comparator: placebo
identical-appearing placebo supplements for 2 years
Drug: placebo
supplement of placebo two times per day for 2 years



Primary Outcome Measures :
  1. Recurrence rates of CRA [ Time Frame: 2 years or 3 years or later ]
    The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.


Secondary Outcome Measures :
  1. The incidence of advanced colorectal adenoma or colorectal cancer [ Time Frame: 2 years or 3 years or later ]
    The incidence of advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention


Other Outcome Measures:
  1. Changes in fecal microflora [ Time Frame: baseline, 1 year and 2 years ]
    Fecal microflora tests

  2. Changes in numbers or diameters of recurrent colorectal adenoma (CRA) [ Time Frame: 2 years or 3 years or later ]
    Colonoscopy follow-up



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged 18-75years
  • Individuals who had at least one histologically confirmed colorectal adenoma removed within 6 months before recruitment
  • Individuals without a history of familial polyposis
  • Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study

Exclusion Criteria:

  • Patients who are hypersensitive or intolerant to the drugs
  • Patients who are intolerant to another colonoscopy examination
  • Patients with hypercalcemia or urolithiasis
  • Pregnant women, women during breast-feeding period, or women with expect pregnancy
  • Patients with diabetes mellitus, severe heart or renal disease, or cancer history
  • Patients with a history of subtotal gastrectomy or partial bowel resection
  • Patients who are not able to cooperate
  • Individual who are involved in designing, planning or performing this clinical trial
  • Patients with medical conditions who are not appropriate to participate the study
  • Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.
  • Patients with inflammatory bowel disease (IBD)
  • Patients with any condition that could be worsened by supplemental Berberine hydrochloride.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226185


Locations
China
Shanghai Institute of Digestive Disease
Shanghai, China, 200001
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jing-Yuan Fang, M.D., Ph.D Shanghai Jiao Tong University School of Medicine
  Study Documents (Full-Text)

Documents provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:

Responsible Party: Jing-yuan Fang, MD, Ph. D, Director of Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02226185     History of Changes
Other Study ID Numbers: RJ2014BH
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Recurrence
Adenoma
Disease Attributes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms