Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
- Conditions
- Nonalcoholic Fatty Liver DiseaseChronic Hepatitis B
- Interventions
- Drug: Chronic Hepatitis B
- Registration Number
- NCT05523648
- Lead Sponsor
- Sichuan Leshan Traditional Chinese Medicine Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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；
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The control group Chronic Hepatitis B The control group was treated with silibinin meglumine tablets and tenofovir The treatment group Chronic Hepatitis B The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sichuan Leshan traditional Chinese medicine hospital
🇨🇳Leshan, China