15/5000 Liver fibrosis associated with chronic viral hepatitis B
Conditions
Interventions
Observation group and :Observation group: Ganshuang granules combined with oral antiviral drugs
control group:Control group: oral antiviral drugs
Sponsors
Beijing You'an Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients clinically diagnosed with chronic hepatitis B meet the antiviral treatment criteria of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) and meet any of the following conditions: ? ALT=1×ULN, LSM=6.0kPa (FibroScan) or LSM=7.3kPa (FibroTouch); ? For initial treatment, 1×ULN < ALT < 2×ULN, LSM=7.4kPa (FibroScan) or LSM=7.3kPa (FibroTouch) ? Patients who have received antiviral therapy for more than 1 year should also satisfy ALT=1×ULN, HBV DNA=20 IU/mL, LSM=6.0kPa (FibroScan) or LSM=7.3kPa (FibroTouch). 2. It meets the diagnostic criteria of liver-stagnation and spleen-deficiency syndrome of TCM; 3. TBil = 2×ULN; 4. Patients aged 18 years and above; 5. The patient was able to successfully complete the detection of liver elastography;
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to the proposed drug; 2) Pregnant and lactating women, or men and women who have plans to have children in the near future; 3) Patients with serious primary diseases such as heart, kidney, brain and hematopoietic system and mental illness; 4) Hepatitis with other liver virus infection, decompensated cirrhosis, moderate to severe fatty liver, autoimmune liver disease, alcoholic liver injury, drug-induced liver injury, genetic metabolic liver disease; 5) Patients who had used drugs with therapeutic effect on liver fibrosis (such as compound Biejia Ruangan tablets/capsules, Fuzheng Huayu tablets/capsules, Anluo Huaxian pills) within 3 months before enrollment; 6) Patients who had used hepatoprotective drugs (including but not limited to: glycyrrheic acid, silymarin, ursodeoxycholic acid, obeccholic acid, polyene phosphatidylcholine, polyunsaturated lecithin, bicyclic alcohols) within 1 month before admission; 7) Suspected or have a history of drug abuse, alcoholism (defined as drinking more than 56g of alcohol in one day (56g of alcohol is equivalent to 1400 mL of beer, 600mL of wine or 176mL of low-alcohol liquor); 8) The researchers believe that other reasons are not suitable for inclusion in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LSM;Hepatitis B virus quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Four items of serum liver fibrosis;Blood biochemistry;FIB-4;APRI; | — |
Countries
china
Contacts
Public ContactDuan zhong ping,Chen Yu
Beijing You'an Hospital Capital Medical University
Outcome results
None listed