6-year Follow-up Data After the Berberine Intervention Trial
NCT ID: NCT06629051
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
891 participants
OBSERVATIONAL
2024-10-04
2024-12-31
Brief Summary
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In 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology \& Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned.
The present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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berberine
post-intervention of berberine
Berberine Hydrochloride
post-intervention of berberine
placebo
post-intervention of placebo tablets
Placebo
Looks the same as berberine
Interventions
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Berberine Hydrochloride
post-intervention of berberine
Placebo
Looks the same as berberine
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Seventh Medical Center of PLA Army General Hospital
OTHER
Zhongshan Hospital Xiamen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Tianjin Medical University General Hospital
OTHER
the Tenth People's Hospital affiliated to Tongji University
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jing-yuan Fang, MD, Ph. D
Division of Gastroenterology & Hepatology, Renji Hospital
Principal Investigators
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Jing-Yuan Fang, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY2024-232-A
Identifier Type: -
Identifier Source: org_study_id
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