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Fuzheng Huayu Tablets for Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated): A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

NCT07663643 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2026-06-23

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Eligible patients will be randomly assigned to receive either Fuzheng Huayu Tablets or placebo for 72 weeks. The primary objective is to assess the improvement in liver fibrosis, measured by liver stiffness reduction via FibroScan. Secondary objectives include changes in liver function indicators, liver fibrosis markers, Child-Pugh score, and safety profile.

Conditions

  • Metabolic Dysfunction-associated Fatty Liver Cirrhosis

Interventions

DRUG

Fuzheng Huayu Tablets

Test group: Fuzheng Huayu Tablets, 4 tablets each time, 3 times daily, orally administered. Control group: Fuzheng Huayu Tablets placebo, 4 tablets each time, 3 times daily, orally administered.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

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
2026-05-25
Primary Completion
2027-10-15
Completion
2029-04-02

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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 NCT07663643 on ClinicalTrials.gov