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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005358
Enrollment
Unknown
Registered
2021-11-29
Start date
2021-12-01
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

compensation period for liver cirrhosis related to hepatitis B

Interventions

Test group :combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir

Sponsors

TCM-Integrated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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;

Design outcomes

Primary

MeasureTime frame
fibroscan;color Doppler ultrasound of liver, bile, pancreas and spleen;

Secondary

MeasureTime frame
liver function;Symptom & Signs;serum indices of hepatic fibrosis;HBV marker;APRI score;FIB-4 score;HBV-DNA;

Countries

China

Contacts

Public ContactSongqi He

TCM-Integrated Hospital of Southern Medical University

hesongqijz@126.com13697499297

Outcome results

None listed

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