CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 337 enrolled
Drug / intervention
Berberine plus lifestyle intervention +1 moredrug
Likely dose
Berberine plus lifestyle intervention 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05647915
NCT05647915Phase 4Completed
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Assess the Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and Non-alcoholic Fatty Liver Disease

China National Center for Cardiovascular Diseases·interventional·Posted Dec 13, 2022·Updated Jan 29, 2025

In Brief

A Phase 4 clinical trial evaluating Berberine plus lifestyle intervention and Placebo plus lifestyle intervention for Obesity and 2 related conditions. Completed, enrolled 337 participants across 1 site.

Detailed Summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Obesity, Abdominal, NAFLD
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 13, 2022
Enrollment StartJul 6, 2023
Primary CompletionAug 9, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.6 years ago

Interventions

Berberine plus lifestyle interventiondrug

berberine hydrochloride 500mg twice a day for 6 months plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

Placebo plus lifestyle interventionbehavioral

Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.