liver fibrosis
Conditions
Interventions
Control group:Placebo combined with first-line antiviral drugs
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients meeting the diagnostic criteria for chronic hepatitis B induced hepatic fibrosis; 2. The pathological results of liver biopsy showed that Ishak stage was F2-F6; 3. Initial patients ( HBeAg-positive patients, HBV-DNA >= 20000IU/ml (equivalent to 10^5 copies/ml); HBeAg-negative patients, HBV-DNA >= 2000IU/ml (equivalent to 10^4 copies/ml) or those who have used entecavir, tenofovir (ester) or other antiviral drugs for more than one year and whose HBV-DNA is below the detection limit; 4. Willing to accept integrated Chinese and Western medicine treatment; 5. The age ranges from 18 to 65 years, with no gender limitation; 6. Signing an informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatitiscaused by other hepatophilic viruses, steatohepatitis, autoimmune hepatitis, alcoholic liver disease and long-term history of traditional Chinese and Western medicine taking hepatotoxicity. 2. The patients with decompensated cirrhosis, such as those with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy, intractable ascites, hemorrhagic tendency, hepatorenal syndrome and primary hepatocellular carcinoma in the past six months. 3. Patients with abnormal AFP and/or liver and spleen B ultrasound or CT or MRI suspicious liver space occupancy. 4. Patients with severe primary diseases of heart, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract; or psychiatric patients. 5. Patients with allergic constitution or allergic to various drugs. 6. Pregnant women or breast-feeding women who are willing to have children in the near future. 7. Patients who used immunomodulators systematically in the past six months. 8. Loss of Fibroscan or Fibrotouch detection due to obesity (BMI > 30), narrow costal space and other factors. 9. Due to other factors, researchers believe that it is not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| five markers of hepatitis;AFP;Hultrasound of hepatobiliary pancreatic spleen;hepatic function;blood routine;four hepatic fibrosis tests;traditional chinese medicine syndrome score scale;Fibroscan; | — |
Countries
China
Contacts
Public ContactGao Yue-qiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine?
Outcome results
None listed