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Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Primary Purpose

Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Chronic Hepatitis B
Sponsored by
Sichuan Leshan Traditional Chinese Medicine Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Sichuan Leshan traditional Chinese medicine hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The control group

The treatment group

Arm Description

The control group was treated with silibinin meglumine tablets and tenofovir

The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir

Outcomes

Primary Outcome Measures

ALT, AST and GGT
Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment
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
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
fat attenuation
The LSM was used to detect and compare fat attenuation parameters in this study

Secondary Outcome Measures

Full Information

First Posted
August 24, 2022
Last Updated
August 29, 2022
Sponsor
Sichuan Leshan Traditional Chinese Medicine Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05523648
Brief Title
Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Official Title
Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Leshan Traditional Chinese Medicine Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
Experimental
Arm Description
The control group was treated with silibinin meglumine tablets and tenofovir
Arm Title
The treatment group
Arm Type
Active Comparator
Arm Description
The treatment group was treated with Ganshuang granules combined with silibinin meglumine tablets and tenofovir
Intervention Type
Drug
Intervention Name(s)
Chronic Hepatitis B
Other Intervention Name(s)
Nonalcoholic Fatty Liver Disease
Intervention 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.
Primary Outcome Measure Information:
Title
ALT, AST and GGT
Description
Alt, AST and GGT were used to evaluate the improvement of liver function before and after treatment
Time Frame
12 and 24 weeks
Title
HBV-DNA serum load < 500 IU/ml
Description
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
Time Frame
12 and 24 weeks
Title
liver stiffness
Description
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
Time Frame
12 and 24 weeks
Title
fat attenuation
Description
The LSM was used to detect and compare fat attenuation parameters in this study
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Yang, MM
Organizational Affiliation
Sichuan Leshan Traditional Chinese Medicine Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sichuan Leshan traditional Chinese medicine hospital
City
Leshan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

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