Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- ALT, AST and GGT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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；
排除标准
- 未提供
研究组 & 干预措施
The control group
The control group was treated with silibinin meglumine tablets and tenofovir
干预措施: Chronic Hepatitis B (Drug)
The treatment group
The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
干预措施: Chronic Hepatitis B (Drug)
结局指标
主要结局
ALT, AST and GGT
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 and 24 weeks
The LSM was used to detect and compare fat attenuation parameters in this study
次要结局
未报告次要终点
研究者
Qin Yang
Deputy chief physician
Sichuan Leshan Traditional Chinese Medicine Hospital