Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
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
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.
Interventions
DRUGChronic Hepatitis B
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.
Sponsors
Sichuan Leshan Traditional Chinese Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALT, AST and GGT | 12 and 24 weeks | Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment |
| HBV-DNA serum load < 500 IU/ml | 12 and 24 weeks | 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 |
| liver stiffness | 12 and 24 weeks | 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 |
| fat attenuation | 12 and 24 weeks | The LSM was used to detect and compare fat attenuation parameters in this study |
Countries
China
Outcome results
None listed