Status:
COMPLETED
A Mechanistic Randomized Controlled Trial on the Cardiovascular Effect of Berberine
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Food and Health Bureau, Hong Kong
Conditions:
Cardiovascular Risk Factor
Eligibility:
MALE
20-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Berberine is extracted from Coptis (Huanglian) and Phellodendron Chinese (Huangbai), to make into berberine tablets.1 Recent studies have shown that berberine has beneficial effects on cardiovascular ...
Detailed Description
Objectives: to assess the effect of berberine on a set of well-established CVD risk factors, including lipids, systolic and diastolic blood pressure, coagulation factors, fasting glucose, insulin, adi...
Eligibility Criteria
Inclusion
- Men, who are
- aged 20 to 65 years
- of Chinese ethnicity
- with hyperlipidemia, defined as TG greater than 150 mg/dl (1.70 mmol/L), TC greater than 200 mg/dl (5.16 mmol/L), and/or LDL-c greater than 100 mg/dl (2.58 mmol/L)
- willing to make return visits
- not currently receiving hormone replacement therapy, such as testosterone replacement therapy, in the past 12 months
- not currently taking berberine or traditional Chinese medicine that contains berberine, in the past 1 month
- free of any congenital diseases, including familial hypercholesterolemia
- free of any infectious diseases, e.g. seasonal influenza
- free of anemia and glucose-6-phosphate dehydrogenase deficiency
- with no history of any chronic diseases including ischemic heart disease, myocardial infarction (heart attack), stroke, diabetes, cancer, liver/renal dysfunction, and gastrointestinal disorders.
Exclusion
- All women, and men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03770325
Start Date
April 1 2019
End Date
November 1 2020
Last Update
November 4 2020
Active Locations (1)
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1
Li Ka Shing Faculty of Medicine
Hong Kong, Hong Kong