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Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

S

Sichuan Leshan Traditional Chinese Medicine Hospital

Status and phase

Completed
Early Phase 1

Conditions

Nonalcoholic Fatty Liver Disease
Chronic Hepatitis B

Treatments

Drug: Chronic Hepatitis B

Study type

Interventional

Funder types

Other

Identifiers

NCT05523648
Qin1651

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

92 participants in 2 patient groups

The control group
Experimental group
Description:
The control group was treated with silibinin meglumine tablets and tenofovir
Treatment:
Drug: Chronic Hepatitis B
The treatment group
Active Comparator group
Description:
The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
Treatment:
Drug: Chronic Hepatitis B

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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