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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200006597
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-13
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

experiment group:Yinqi Sanhuang Jiedu Decoction+Entecavir
EnYQSHJD+En

Sponsors

Guang'anmen Hospital, China academy of Chinese medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
subtype of T cell;subtype of B cell;subtype of monocyte;

Countries

china

Contacts

Public ContactCheng AN
aangcheng@126.com88001489

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026