Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Chronic Hepatitis B Clinical Trial

Official title:

Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523648
• Other study ID #: Qin1651
• Status: Completed
• Phase: Early Phase 1
• Start date: January 5, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: August 2022
• Source: Sichuan Leshan Traditional Chinese Medicine Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 21, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Fatty Liver
• Hepatitis B
• Hepatitis B, Chronic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Drug:
• Chronic 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.

Locations

Country	Name	City	State
China	Sichuan Leshan traditional Chinese medicine hospital	Leshan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Leshan Traditional Chinese Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	fat attenuation	The LSM was used to detect and compare fat attenuation parameters in this study	12 and 24 weeks