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Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

NCT03198572 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-08

No results posted yet for this study

Summary

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

Conditions

  • Non-alcoholic Steatohepatitis

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • The Affiliated Hospital of Hangzhou Normal University

    collaborator OTHER

  • Tianjin Third Central Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Xinjiang Medical University

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Xin Gao · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2023-12-30
Completion
2024-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03198572 on ClinicalTrials.gov