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

NCT06782646 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Jie Zhao, Dr · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782646 on ClinicalTrials.gov