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The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules

NCT05042245 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-03-16

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. The hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Ornithine aspartate granule

Ornithine aspartate granules in the experimental arm.

DRUG

Silymarin capsule

Silymarin capsules in the active comparator arm.

DRUG

Silymarin capsule simulant

Silymarin capsule simulant in the experimental arm.

DRUG

Ornithine aspartate granule simulant

Ornithine aspartate granule simulant in the active comparator arm.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Beijing YouAn Hospital

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jian G Fan, PHD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2022-12-18
Completion
2022-12-20

Countries

  • China

Study Locations

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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 NCT05042245 on ClinicalTrials.gov