Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Chronic Hepatitis B

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Leshan, China
    • Sichuan Leshan traditional Chinese medicine hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The control group; The control group was treated with silibinin meglumine tablets and tenofovir	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.; Other Names: Nonalcoholic Fatty Liver Disease
Active Comparator: The treatment group; The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir	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.; Other Names: Nonalcoholic Fatty Liver Disease

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sichuan Leshan Traditional Chinese Medicine Hospital
• Investigators: Study Chair: Qin Yang, MM, Sichuan Leshan traditional Chinese medicine hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Hepatitis B; Fatty Liver; Hepatitis B, Chronic; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Qin1651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No