Liver fibrosis
Conditions
Interventions
Control group:Baqi Ruogan Recipe 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 diagnostic criteria for chronic hepatitis B liver fibrosis with spleen and kidney deficiency combined with blood stasis obstruction syndrome; 3. The pathological results of liver biopsy showed that Ishak stage was F2-F5; 4. Initial patients or those who have used antiviral drugs for more than one year and whose HBV-DNA is below the detection limit; 5. Willing to accept integrated Chinese and Western medicine treatment; 6. The age ranges from 18 to 65 years, with no gender limitation; 7. 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; 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. 10. There are contraindications for MRI scanning, including but not limited to: severe autism, inner ear implants, pacemakers or other implanted rhythm management devices, intracranial aneurysm clips that are incompatible with MRI, any other metal, non MRI compatible implanted devices, and a history of metal fragments in the body that have not been removed. 11. Participated in other intervention clinical trials within the first 12 weeks of screening. 12. The researcher believes that there are other situations that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ishak score of Liver; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver hardness value via magnetic resonance elastography;The liver elasticity value of instantaneous elastography;APRI score;FIB-4 index;HBsAg;B Ultrasound of Upper Abdomen;Traditional Chinese Medicine Syndrome Quantity Integral;HBV-DNA;HBV-DNA;Four items of liver fibrosis; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed