Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

NCT07017426 | Not Yet Recruiting DMC

• 1 other identifier: BJDHYZYFZHY
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to conduct a prospective, multicenter, double-blind, randomized, placebo-controlled trial. The planned sample size is 432 patients, with the ratio of the Fuzheng Huayu group to the placebo control group being 1:1. Participants will be randomly assigned to the two groups using a stratified block randomization method at the central level. The Fuzheng Huayu group (Fuzheng Huayu tablets combined with conventional antiviral therapy) and the placebo group (placebo combined with conventional antiviral therapy) will be treated for 48 weeks, followed by a 96-week follow-up. The study period will last for a total of 2 years. The cumulative incidence of recurrent decompensation events within 1 year, the cumulative incidence of recompensation within 1 year, the incidence of liver failure, liver cancer, and liver disease-related deaths will be analyzed. The efficacy and safety of Fuzheng Huayu tablets in reducing the recurrence of decompensation events in patients with first-time decompensated hepatitis B cirrhosis will be clarified, providing a basis for clinical practice.

Conditions

Decompensated Hepatitis B Cirrhosis

Outcome Measures

Primary Outcomes (1)

• the cumulative incidence of recurrent decompensation events

  1 year

Secondary Outcomes (4)

• the cumulative incidence of recompensation

  1 year

• the incidence of liver failure

  1 year and 2 year

• the incidence of liver cancer

  1 year and 2 year

• the incidence of liver disease-related deaths

  1 year and 2 year

Study Arms (2)

Fuzheng Huayu tablets combined with conventional antiviral therapy

EXPERIMENTAL

Drug: Fuzheng Huayu tablets

placebo combined with conventional antiviral therapy

PLACEBO COMPARATOR

Other: Placebo Comparator

Interventions

Fuzheng Huayu tablets DRUG

Fuzheng Huayu Tablets are composed of various medicinal ingredients such as Salvia miltiorrhiza, Prunus persica seed, Gynostemma pentaphyllum, pine pollen, Cordyceps sinensis, and Schisandra chinensis. They have the functions of promoting blood circulation and removing blood stasis, nourishing the liver and enriching essence, and can be used to treat chronic liver diseases, anti-fibrosis, and patients with liver cirrhosis.

Fuzheng Huayu tablets combined with conventional antiviral therapy

Placebo Comparator OTHER

placebo combined with conventional antiviral therapy

placebo combined with conventional antiviral therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily joining the group, able to understand and sign informed consent forms;
• Age range: 18-80 years old, gender not limited;
• HBsAg positive for ≥ 6 months during screening;
• Complies with traditional Chinese medicine syndrome types: blood stasis obstructing collaterals, liver and kidney deficiency syndrome;
• The first decompensated event, which meets the diagnostic criteria for decompensated cirrhosis in the "Diagnosis and Treatment Guidelines for Cirrhosis (2019 Edition)": (1) having diagnostic evidence for cirrhosis; (2) Complications related to portal hypertension may occur, such as ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.

You may not qualify if:

• Merge hepatitis A, C, D, E, and/or HIV infections;
• Merge autoimmune liver disease, alcoholic liver disease, drug-induced liver disease and other liver diseases;
• Patients with combined malignant tumors;
• History of splenectomy and transjugular intrahepatic portosystemic shunt surgery;
• Individuals with neurological and psychiatric disorders, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression);
• Individuals with severe heart, lung, kidney and other organ disorders;
• Individuals who plan to undergo organ transplantation or have already undergone organ transplantation;
• Pregnant or lactating women or those with fertility plans during the study period;
• For those who are allergic to tonifying the body and removing blood stasis, nucleoside (acid) analogues, or drugs, or who meet any contraindications in the research drug instructions;
• Individuals who have taken traditional Chinese medicine such as Fuzheng Huayu within the past 6 months;
• The population diagnosed with liver cancer 3 months after enrollment.

Sponsors & Collaborators

• Zhiyun Yang: lead

MeSH Terms

Interventions

fuzheng huayu

Central Study Contacts

Zhi yun Yang, Doctor

CONTACT

+86 13439696988; yangzhiyun2016@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Beijing Ditan Hospital Affiliated to Capital Medical University Affiliation: Beijing Ditan Hospital

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06