To explore the mechanism of Yinqi Sanhuang Jiedu Decoction in the treatment of chronic hepatitis B based on refined immune function indexes

Not Applicable

Not yet recruiting

• Conditions: Chronic hepatitis B

• Registration Number: ITMCTR2200006597
• Lead Sponsor: Guang'anmen Hospital, China academy of Chinese medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

According to the diagnostic criteria for chronic hepatitis B (2015 Edition) and the diagnostic criteria for primary liver cancer (2000 Edition), patients with chronic hepatitis B: those with a history of hepatitis B or HBsAg positive for more than 6 months, who are still positive for HBsAg and / or HBV DNA, and whose ALT is continuously or repeatedly increased. ? Patients with chronic hepatitis B fibrosis / cirrhosis in the compensatory stage: Patients with previous history of hepatitis B or HBsAg positive, with dysfunction of hepatocyte synthesis or portal hypertension but no bleeding or ascites; ? Decompensated patients with chronic hepatitis B cirrhosis: previous history of hepatitis B or HBsAg positive, accompanied by esophageal and gastric variceal bleeding, hepatic encephalopathy, ascites, etc; ? Patients with chronic hepatitis B virus related liver cancer: they have a history of hepatitis B, AFP > 400ug / L, can exclude active liver disease, pregnancy, germline embryogenic tumor and metastatic liver disease, and can touch hard and lumpy liver or imaging examination with characteristic space occupying lesions of liver cancer; In the patients with AFP < 400ug / L, there were two kinds of space occupying lesions with liver cancer characteristics or two kinds of liver cancer markers (AFP heterogeneity, abnormal prothrombin, r-glutamyltranspeptidase isozyme II and a-L-Fucosidase, etc.) positive and one kind of space occupying lesions with liver cancer characteristics on imaging examination; ? Health examination personnel; Blood routine, routine biochemistry (Glu, BUN, Cr, ALT, AST), tumor markers (AFP, CEA, CA125, CA153, PSA, CA724, CA199), chest imaging and abdominal ultrasound were normal, without tumor disease history, autoimmune disease, allergic disease, immune related disease, and apparent health.

Exclusion Criteria

Combined with other viral infections, such as HIV, HCV, HDV infection, oral immunosuppressants, organ transplantation, and other diseases affecting the immune system;
Baseline survey: antiviral treatment, alcoholic hepatitis, alcoholic fatty liver, obese fatty liver, etc.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
subtype of T cell;subtype of B cell;subtype of monocyte;