Decompensated Hepatitis B CirrhosisFZHYRORDFDHBLCNCT07017426
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
A study testing Fuzheng Huayu tablets in people with Decompensated Hepatitis B Cirrhosis, run by Zhiyun Yang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decompensated Hepatitis B Cirrhosis
- What is being tested?
- Fuzheng Huayu tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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;
- Other situations that have participated in other intervention studies within the previous 3 months or are deemed unsuitable for inclusion by the researchers;
- The population diagnosed with liver cancer 3 months after enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Fuzheng Huayu tablets, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Huayu tabletsDrug
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.
Placebo ComparatorOther
placebo combined with conventional antiviral therapy
| Study group | Role | What they receive |
|---|---|---|
| Fuzheng Huayu tablets combined with conventional antiviral therapy | Experimental | Not described Receives: Drug: Fuzheng Huayu tablets |
| placebo combined with conventional antiviral therapy | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative incidence of recurrent decompensation events
Measured: 1 year
Secondary outcomes (4)
the cumulative incidence of recompensation
Measured: 1 year
the incidence of liver failure
Measured: 1 year and 2 year
the incidence of liver cancer
Measured: 1 year and 2 year
the incidence of liver disease-related deaths
Measured: 1 year and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decompensated Hepatitis B CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyun Yang, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017426
- Sponsor's protocol ID
- BJDHYZYFZHY
- Acronym
- FZHYRORDFDHBLC
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu L, Peng W, Shi W, Ma H, Li J, Zhou Y, Miao J, Hou Y, Wang Q, Yang Z. Fuzheng Huayu tablets reduces the risk of further decompensation after the first decompensation in patients with HBV-related cirrhosis: protocol for a randomized, double-blind, placebo-controlled, multicenter trial. Front Pharmacol. 2026 Jul 2;17:1828944. doi: 10.3389/fphar.2026.1828944. eCollection 2026.
PubMed 42465987
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07017426
- Acronym / sponsor ID
- FZHYRORDFDHBLC / BJDHYZYFZHY
- Conditions
- Decompensated Hepatitis B Cirrhosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Zhiyun YangUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuzheng Huayu tablets combined with conventional antiviral therapy | Experimental | Drug: Fuzheng Huayu tablets |
| placebo combined with conventional antiviral therapy | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fuzheng Huayu tabletsFuzheng 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. | Drug | Fuzheng Huayu tablets combined with conventional antiviral therapy |
| Placebo Comparatorplacebo combined with conventional antiviral therapy | Other | placebo combined with conventional antiviral therapy |
Primary outcome
the cumulative incidence of recurrent decompensation events
Time frame: 1 year
4 secondary outcomes
the cumulative incidence of recompensation
Time frame: 1 year
the incidence of liver failure
Time frame: 1 year and 2 year
the incidence of liver cancer
Time frame: 1 year and 2 year
the incidence of liver disease-related deaths
Time frame: 1 year and 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 42465987Yu L, Peng W, Shi W, Ma H, Li J, Zhou Y, Miao J, Hou Y, Wang Q, Yang Z. Fuzheng Huayu tablets reduces the risk of further decompensation after the first decompensation in patients with HBV-related cirrhosis: protocol for a randomized, double-blind, placebo-controlled, multicenter trial. Front Pharmacol. 2026 Jul 2;17:1828944. doi: 10.3389/fphar.2026.1828944. eCollection 2026.
Related trials for Decompensated Hepatitis B Cirrhosis
RecruitingPhase 4
Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver
Hepatitis B
Active, not recruitingObservational study
Clinical Characteristics of Recompensation
Cirrhosis, Alcohol Related Liver Disease
RecruitingPhase 1
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Hepatitis B
RecruitingPhase 1/2
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
Decompensated Hepatitis B Cirrhosis
Not yet recruitingObservational study
A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Fuzheng Huayu tablets in people with Decompensated Hepatitis B Cirrhosis, run by Zhiyun Yang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi yun Yang, Doctor (+86 13439696988, yangzhiyun2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cumulative incidence of recurrent decompensation events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.