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ACTIVE NOT RECRUITING
NCT05749874
PHASE4

Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine on preventing cardiovascular disease and diabetes mellitus among individuals with high cardiometabolic risk in China.

Official title: Assess the Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus Among Individuals With High Cardiometabolic Risk

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2024

Start Date

2023-10-31

Completion Date

2026-12-31

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

Berberine plus lifestyle intervention

berberine hydrochloride 500mg twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.

BEHAVIORAL

Placebo plus lifestyle intervention

Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

Beijing, China