Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence
NCT ID: NCT02226185
Last Updated: 2019-03-26
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
1108 participants
INTERVENTIONAL
2014-11-30
2018-12-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
placebo
identical-appearing placebo supplements for 2-3 years
placebo
supplement of placebo two times per day for 2-3 years
Interventions
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Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
placebo
supplement of placebo two times per day for 2-3 years
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jing-yuan Fang, MD, Ph. D
Director of Department of Gastroenterology
Principal Investigators
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Jing-Yuan Fang, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, Fujian, China
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, Guangzhou, China
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
Nanjing, Jiangsu, China
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 Municipality, China
Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
Countries
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References
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Qian Y, Kang Z, Zhao L, Chen H, Zhou C, Gao Q, Wang Z, Liu Q, Cui Y, Li X, Chen Y, Zou T, Fang J. Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula. Chin Med J (Engl). 2023 Nov 20;136(22):2722-2731. doi: 10.1097/CM9.0000000000002752. Epub 2023 Aug 9.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RJ2014BH
Identifier Type: -
Identifier Source: org_study_id
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