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TERMINATED
NCT03198572
PHASE2

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.

Official title: Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

89

Start Date

2017-08-16

Completion Date

2025-02-20

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Lifestyle intervention

Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.

DRUG

Placebo

placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks

DRUG

Berberine

Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks

Locations (6)

Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, China

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Tianjin Third Central Hospital

Tianjin, China

Xinjiang Medical University

Ürümqi, China