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ENROLLING BY INVITATION
NCT06782646
PHASE2/PHASE3

Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if berberine works to affect lipids and lipoproteins in Chinese females aged 20 to 65 years with hyperlipidaemia. The goal also includes to examine the sex-specific effect of berberine on lipids and lipoproteins. Our previous HMRF-funded randomized trial in men and prior evidence suggests berberine affects sex hormones. Given the different sex hormone profiles in men and women, the main question it aims to answer is: • Does berberine have sex-specific lipid-modifying effects? Researchers will compare berberine to a placebo (a look-alike substance that contains no drug) to see if berberine works to affect lipids and lipoproteins. Participants will: * Take a baseline questionnaire * Take berberine or a placebo every day for 12 weeks * Take follow-up visits after 8 weeks and 12 weeks for blood sample collections and tests

Official title: Assessing the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine Using Randomized, Placebo-controlled, Double-masked Trial

Key Details

Gender

FEMALE

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-08-01

Completion Date

2026-03

Last Updated

2025-01-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Berberine

Participants will take purified berberine (500 mg orally twice a day) for 12 weeks.

DRUG

Placebo

Participants will take placebo tablets, a look-alike substance that contains no drug, (500 mg orally twice a day) for 12 weeks.

Locations (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong