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Study on clinical efficacy of combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir in the treatment of compensated patients with liver cirrhosis related to hepatitis B

Not Applicable
Conditions
compensation period for liver cirrhosis related to hepatitis B
Registration Number
ITMCTR2100005358
Lead Sponsor
TCM-Integrated Hospital of Southern Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1)meet the western medical diagnostic criteria for the compensation period for liver cirrhosis related to hepatitis B; (2)meet the diagnostic criteria for Chinese medicine for Gan Dan Shi Re Jia Yu;(3)meet the antiviral standards for hepatitis B;(4)not use any antiviral drugs other than Entecavir within 3 months of diagnosis;(5)age 18-65 years old at the time of diagnosis, gender unlimited;(6)Informed consent and treatment and treatment-related laboratory examination, and can answer questions truthfully.

Exclusion Criteria

(1) Testing for sero HIV; (2) combining other viral liver diseases, non-alcoholic fatty hepatitis, explicit drug-damaging liver disease, self-free liver and other chronic liver diseases; (3) the combination of other chronic severe hepatitis, liver cirrhosis, liver cancer and other serious or terminal liver disease; (4) other diseases seriously affect their quality of life. If there are severe organ dysfunction and severe diabetes, liver and kidney syndrome, liver and lung syndrome or other severe trauma caused by liver disease;

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
fibroscan;color Doppler ultrasound of liver, bile, pancreas and spleen;
Secondary Outcome Measures
NameTimeMethod
liver function;Symptom & Signs;serum indices of hepatic fibrosis;HBV marker;APRI score;FIB-4 score;HBV-DNA;
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