Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
NCT ID: NCT05523648
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
92 participants
INTERVENTIONAL
2020-01-05
2021-12-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The control group
The control group was treated with silibinin meglumine tablets and tenofovir
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.
The treatment group
The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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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；
20 Years
55 Years
ALL
No
Sponsors
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Sichuan Leshan Traditional Chinese Medicine Hospital
OTHER
Responsible Party
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Qin Yang
Deputy chief physician
Principal Investigators
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Qin Yang, MM
Role: STUDY_CHAIR
Sichuan Leshan Traditional Chinese Medicine Hospital
Locations
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Sichuan Leshan traditional Chinese medicine hospital
Leshan, , China
Countries
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References
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Su C, Yang Q. Clinical study of ganshuang granule combined with tenofovir in the treatment of chronic hepatitis B complicated with nonalcoholic fatty liver disease. Front Pharmacol. 2022 Dec 14;13:1032789. doi: 10.3389/fphar.2022.1032789. eCollection 2022.
Other Identifiers
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Qin1651
Identifier Type: -
Identifier Source: org_study_id