Status:
COMPLETED
Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Colorectal Adenoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2018
Estimated Enrollment :
1108 Patients enrolled
Trial Details
Trial ID
NCT02226185
Start Date
November 1 2014
End Date
December 29 2018
Last Update
March 26 2019
Active Locations (7)
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1
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
2
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, Fujian, China
3
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, Guangzhou, China
4
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
Nanjing, Jiangsu, China