Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Study Overview
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Brief Summary
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The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.

Detailed Description
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92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise. The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch: 200304) and tenofovir (QILU Pharmaceutical Co., Ltd.; National medicine permission number: H20173185; Production batch: 1L0694DF6). The use of silymarin glucosamine tablets was 0.2g/d, 3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks. The treatment group was treated with Ganshuang granules (Baoding Tianhao Pharmaceutical Co., Ltd.; National medicine permission number: Z20027671; Production batch: 200326 ) combined with silibinin meglumine tablets and tenofovir. Libribin meglumine tablets and tenofovir were used in the same way as in the control group, and Ganshuang granules were used 3 g/time, 3 times/d, and the course of treatment was 24 weeks.

Official Title
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Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Conditions
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Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Chronic Hepatitis B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis B patients not treated with antiviral drugs； Fatty liver was diagnosed by B-ultrasound and imaging； No history of excessive drinking； Good drug compliance and regular medication； Exclusion Criteria： Non chronic hepatitis B patients； Taking other drugs； liver failure, liver cancer and other diseases； patients who refused to sign informed consent；

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The control group<br>The control group was treated with silibinin meglumine tablets and tenofovir | Drug: Chronic Hepatitis B<br>* 92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.<br>* Other names: Nonalcoholic Fatty Liver Disease;|
| Active Comparator: The treatment group<br>The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir | Drug: Chronic Hepatitis B<br>* 92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.<br>* Other names: Nonalcoholic Fatty Liver Disease;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT, AST and GGT | Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment | 12 and 24 weeks | 
| HBV-DNA serum load < 500 IU/ml | To verify the effect of the drug on the clearance of hepatitis B virus, the number of patients with HBV-DNA serum load < 500 IU/ml before and after treatment was counted in this study | 12 and 24 weeks | 
| liver stiffness | In our study, liver sclerosis index was detected using LSM to compare the improvement of liver stiffness before and after treatment in the two groups | 12 and 24 weeks | 
| fat attenuation | The LSM was used to detect and compare fat attenuation parameters in this study | 12 and 24 weeks |