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Completed

NCT Number: NCT05523648

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fatty Liver Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sichuan Leshan traditional Chinese medicine hospital

Leshan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；

Treatment and study plan

Chronic Hepatitis B

Drug

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

Primary outcomes

  1. ALT, AST and GGT

    Time frame: 12 and 24 weeks

    Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment

  2. HBV-DNA serum load < 500 IU/ml

    Time frame: 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

  3. liver stiffness

    Time frame: 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

  4. fat attenuation

    Time frame: 12 and 24 weeks

    The LSM was used to detect and compare fat attenuation parameters in this study

Sponsors and collaborators

Lead sponsor

Sichuan Leshan Traditional Chinese Medicine Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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