Hepatitis B virus-related Decompensated Cirrhosis
Conditions
Interventions
the trial group:Compound 386 granule combined with nucleotide analogue
the placebo control group:placebo combined with nucleotide analogue
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 68 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 ~ 68 years old, regardless of sex; (2) Meet the diagnostic criteria of hepatitis B cirrhosis; (3) WIth CTP B; (4) TCM syndrome differentiation with liver and kidney yin deficiency as the main witness; (5) being or wlii be treated with nucleotide analogues; (6) The patient or his/her guardian agree to participate in the the randomized controlled trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) liver failure; (2) Hepatitis associated with other hepatitis viruses, NAFLD, a long history of alcohol use, or other chronic severe hepatitis; (3) Women who are pregnant or planning to become pregnant, or breastfeeding women; (4) There are serious basic diseases: incluing severe chronic obstructive pulmonary disease, severe renal insufficiency, chronic congestive heart failure, etc. (5) Immunodeficiency patients: such as malignant tumors, organ transplantation and AIDS, or taking immunosuppressants or glucocorticoids in the past three months; (6) Participating in other clinical trials; (7) Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| CTP score;virological examination;the incidence of liver failure;incidence of liver malignancy;changes in MELD scores from baseline;blood routine;liver function;renal function;coagulation;B-ultrasound;FibroScan; | — |
Countries
China
Contacts
Public ContactPing Liu
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed