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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuzheng Huayu tablets combined with conventional antiviral therapy | Experimental |
| |
| placebo combined with conventional antiviral therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the cumulative incidence of recurrent decompensation events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the cumulative incidence of recompensation | 1 year | |
| the incidence of liver failure | 1 year and 2 year | |
| the incidence of liver cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi yun Yang, Doctor | Contact | +86 13439696988 | yangzhiyun2016@163.com |
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|
| Placebo Comparator | Other | placebo combined with conventional antiviral therapy |
|
| 1 year and 2 year |
| the incidence of liver disease-related deaths | 1 year and 2 year |
| ID | Term |
|---|---|
| C532829 | fuzheng huayu |
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