Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence - Full Text View

Purpose

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	Intervention	Phase
Colorectal Adenoma	Drug: Berberine hydrochloride	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Further study details as provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

The incidences of advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention [ Time Frame: 3 years ]

Other Outcome Measures:

changes in fecal microflora [ Time Frame: baseline and 3 years ]
changes in numbers or diameters of recurrent colorectal adenoma (CRA) [ Time Frame: baseline and 3 years ]


Estimated Enrollment:	200
Study Start Date:	December 2014
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Berberine hydrochloride supplement of Berberine hydrochloride 0.3g two times per day for 3 years	Drug: Berberine hydrochloride supplement of Berberine hydrochloride 0.3g two times per day for 3 years Other Name: Berberine hydrochloride ("Sine Tianping")
Placebo Comparator: placebo identical-appearing placebo supplements for 3 years

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals aged 18-65years
Individuals who had at least one histologically confirmed colorectal adenoma of 1 cm in diameter removed within 12 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02226185

Contacts


Contact: Jing-Yuan Fang, M.D., Ph.D	86-21-53882450	fangjingyuan_new@163.com

Locations


China
Shanghai Institute of Digestive Disease	Recruiting
Shanghai, China, 200001
Principal Investigator: jing-yuan Fang, MD. Ph D.

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

More Information


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
Study First Received:	August 23, 2014
Last Updated:	May 26, 2015

Additional relevant MeSH terms:


Recurrence Adenoma Disease Attributes Pathologic Processes	Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms

ClinicalTrials.gov processed this record on July 11, 2017