Liver Cirrhosis
Conditions
Interventions
control group:Chinese herbal medicine placebo combined with entecavir
treatment group:Chinese herbal medicine plus entecavir
Sponsors
No.5 Beixiange Street, Xicheng District, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: (1) Patients who meet the diagnostic criteria for compensated hepatitis B cirrhosis; 2: (2) Patients who meet the TCM syndrome differentiation criteria for syndrome of qi deficiency and blood stasis with toxin damaging liver collaterals; 3: (3) Patients aged 18–70 years, regardless of gender; 4: (4) Patients who have signed the informed consent form for participation in the study.
Exclusion criteria
Exclusion criteria: 1: (1) Patients with cirrhosis complicated by non-HBV hepatotropic viral infections, autoimmune liver disease, hereditary metabolic liver disease, drug- or toxin-induced liver disease, or alcoholic liver disease; 2: (2) Patients in whom B-ultrasound or MRI detects or suspects space-occupying lesions indicative of primary hepatocellular carcinoma; 3: (3) Women who are pregnant, breastfeeding, or planning to become pregnant during the clinical study; 4: (4) Patients with a known allergy to the investigational drug(s); 5: (5) Patients with psychiatric abnormalities that preclude cooperation in the study, or patients with unstable epilepsy; 6: (6) Patients with severe systemic diseases involving the heart, brain, lungs, kidneys, hematopoietic system, etc.; 7: (7) Patients deemed unsuitable for investigational drug observation for other reasons, or those unable to cooperate with treatment, making it difficult to accurately evaluate the efficacy and safety of the drug; 8: (8) Any other circumstances considered by the investigator as inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving an absolute LSM reduction of =3 kPa; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual incidence rate of hepatocellular carcinoma;Liver biochemistry;Viral serology;AFP;APRI;FIB-4;TCM Syndrome Efficacy Score;Incidence rate of liver-related events; | — |
Countries
china
Contacts
Public ContactWenliang Lv
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed