Clinical efficacy evaluation of Baqi Ruogan Recipe in the treatment of Chronic hepatitis B-induced liver fibrosis

Phase 1

Conditions: liver fibrosis

Registration Number: ITMCTR2200006707

Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
liver biopsy;

Secondary Outcome Measures

Name	Time	Method
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;