decompensated hepatitis B cirrhosis
Conditions
Interventions
Biejiajian Pill control group:Basic treatment and conventional symptomatic treatment
Biejiajian Pill treatment group:Take Biejiajian Pill with basic treatment and conventional symptomatic treatment
Xiaozhang Decoction treatment group:Take Xiaozhang Decoction with basic treatment and conventional symptomatic treatment
Xiaozhang Decoction control group:Basic treatment and conventional symptomatic treatment
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of decompensated hepatitis B cirrhosis and the cirrhosis should be in stage 3. 2.First presentation of ascites within 1 year. 3. Age range from 18 to 70 years with all genders. 4. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other concomitant chronic liver diseases including hepatitis C alcoholic-related liver disease severe non-alcoholic fatty liver disease drug-induced liver injury autoimmune liver disease or genetic liver diseases. 2. History of gastroesophageal variceal bleeding (VB) hepatic encephalopathy (HE) hepatorenal syndrome or hepatopulmonary syndrome. 3. A Child-Pugh score > 12 points. 4. Creatinine >1.5× the normal upper limit at screening. 5. Complicate with any malignant tumour (excluding cured ones). 6. Dysfunction of the heart lungs kidneys brain blood or other vital organs. 7. Serious mental illness. 8. Pregnant and breast-feeding females those who have a desire to conceive recently or the disabled legally. 9. Patients suspected of primary liver cancer by ultrasound or MRI. 10. Patients who have participated in other drug clinical trials within 3 months before screening. 11. Patients who are unable or unwilling to sign informed consent form or unable to comply with experimental requirements. 12. Other situations that researcher determines the patients are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recompensation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PC?;HBsAg(includ dilution);MRE;CIV;LN;varix condition in gastroscopy;PLT;TCM syndrome scale;WBC;Cr;Child-Pugh score;serum albumin;PAB;HBeAg;AFP;upper abdominal enhanced MRI;HBcAb;HA;Liver Fibroscan;HBeAb;RBC;APRI score;PT;GGT;HGB;ascites ultrasound;AST;BUN;quality of life scale;AFP-L3;upper abdominal ultrasound;MELD score;FIB4 index;AKP;HBsAb;TBIL;ALT;INR;HBV DNA; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed