Hepatitis B-related cirrhosis?
Conditions
Interventions
Treatment group(Syndrome of liver-kidney yin deficiency complicated by static blood blocking collaterals?):Liver-Soothing Formula and Basic treatment [first-line nucleoside (acid) analogue antiviral t
Control group(Syndrome of liver-kidney yin deficiency complicated by static blood blocking collaterals?):Liver-Soothing Formula Placebo and Basic treatment [first-line nucleoside (acid) analogue antiv
Treatment group(Syndrome of spleen-kidney deficiency complicated by damp-heat and blood stasis?):?Qiling Xiaji Formula and Basic treatment [first-line nucleoside (acid) analogue antiviral therapy]
Control group(Syndrome of spleen-kidney deficiency complicated by damp-heat and blood stasis?):Qiling Xiaji Formula Placebo and Basic treatment [first-line nucleoside (acid) analogue antiviral therapy
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the diagnostic criteria of compensatory hepatitis B cirrhosis (histology or MRE criteria). 2. According to the traditional Chinese medicine syndrome diagnosis of spleen and kidney deficiency combined with dampness, hot blood and blood stasis, or liver and kidney yin deficiency combined with blood stasis and obstruction of collaterals. 3.Age between 18 and 65 years old, gender not limited. 4.Antiviral treatment for more than 1 year, HBV-DNA<20IU/ml. 5. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suspected liver cancer; 2. Complicated with other liver diseases; 3. Child-Pugh class C; 4. ALT =5 × ULN or AST =5 × ULN or TBil =3 × ULN, Scr =1.5 × ULN; 5.Complicated with other organ dysfunction or malignant tumors; 6.Pregnant or lactating women, or those with recent fertility intentions; 7.Severe mental illness; 8.Participation in other drug clinical trials within 3 months prior to screening.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| MRE Stiffness Values;LSM Stiffness Values;Liver cirrhosis decompensation rate;liver cancer incidence rate;CTP score improvement rate;MELD score improvement rate;Changes in the total score of TCM syndromes;Changes in TCM single symptom scores;Traditional Chinese Medicine syndrome effective rate;Liver related mortality rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Cirrhosis reversal rate; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed