NCT03198572

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-16
• Primary completion: 2023-12-30
• Completion: 2024-07-30
• First posted: 2017-06-26
• Last updated: 2023-08-08

Locations

6 sites across 1 country: China