Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
1 other identifier
interventional
92
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedAugust 31, 2022
August 1, 2022
2 years
August 24, 2022
August 29, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
The control group
EXPERIMENTALThe control group was treated with silibinin meglumine tablets and tenofovir
The treatment group
ACTIVE COMPARATORThe treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Leshan traditional Chinese medicine hospital
Leshan, China
Related Publications (1)
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.
PMID: 36588741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qin Yang, MM
Sichuan Leshan Traditional Chinese Medicine Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy chief physician
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 31, 2022
Study Start
January 5, 2020
Primary Completion
December 20, 2021
Study Completion
December 21, 2021
Last Updated
August 31, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share