Chronic hepatitis B/Chronic hepatitis B cirrhosis
Conditions
Interventions
treatment group(Research Three):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b+ Baqi Lingmao Formula adjusted according to the evidence
control group(Research One):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b+ Baqi Lingmao Formula placebo
control group(Research Two):NAs(ETV or TDF or TAF or TMF)+ Baqi Rougan Formula placebo
treatment group(Research Two):NAs(ETV or TDF or TAF or TMF)+ Baqi Rougan Formula
control group(Research Four):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b
treatment group(Research Four):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b+ Baqi Lingmao Formula adjusted according to the evidence
control group(Research Three):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b
treatment group(Research One):NAs(ETV or TDF or TAF or TMF)+ PEG-IFNa-2b+ Baqi Lingmao Formula
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: Research One Randomized controlled trial on the improvement of clinical cure rate of viral hepatitis by combining traditional Chinese and Western medicine treatment (1) At the time of enrollment meets the diagnostic criteria for CHB patients of HBeAg negative whom are spleen and kidney deficiency with liver and gallbladder damp heat syndrome). (2) Use NAs drugs continuously for at least 6 months before screening with HBsAg =1500IU/mL and HBV-DNA<50IU/mL. (3) Age between 18-65 years old (including 18 and 65 years old at the time of signing the informed consent form) gender is not limited. (4) Within 24 hours before the first medication if the pregnancy test is negative (for women of childbearing age); And the subjects should take effective contraceptive measures during the study period. (5) Sign the informed consent form. Research Two A randomized controlled trial on the improvement of the reversal rate of viral hepatitis cirrhosis by combining traditional Chinese and Western medicine treatment (1) At the time of enrollment it met the diagnostic criteria for patients with CHB cirrhosis (spleen kidney deficiency with blood stasis and obstruction of collaterals). (2) Age between 18-65 years old (including 18 and 65 years old at the time of signing the informed consent form) gender is not limited. (3) Antiviral therapy for more than 1 year HBV DNA negative. Research Three Real world study on the improvement of HBeAg seroconversion rate in NAs treated HBeAg positive CHB patients through integrated traditional Chinese and Western medicine treatment plan (1) At the time of enrollment it met the diagnostic criteria for HBeAg positive CHB patients (spleen and kidney deficiency with liver and gallbladder damp heat syndrome). (2) Antiviral therapy for more than 1 year HBV DNA negative. (3) Age between 18-65 years old (including 18 and 65 years old at the time of signing the informed consent form) gender is not limited. (4) Within 24 hours before the first medication if the pregnancy test is negative (for women of childbearing age); And the subjects should take effective contraceptive measures during the study period. (5) Sign the informed consent form. Research Four Real world study on the improvement of HBsAg seroconversion rate in NAs treated HBeAg negative CHB patients using a combination of traditional Chinese and Western medicine treatment plan (1) At the time of enrollment it met the diagnostic criteria for HBeAg negative CHB patients (spleen and kidney deficiency with liver and gallbladder damp heat syndrome). (2) Antiviral therapy for more than 1 year HBV DNA negative. (3) Age between 18-65 years old (including 18 and 65 years old at the time of signing the informed consent form) gender is not limited. (4) Within 24 hours before the first medication if the pregnancy test is negative (for women of childbearing age); And the subjects should take effective contraceptive measures during the study period. (5) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: Research One Randomized controlled trial on the improvement of clinical cure rate of viral hepatitis by combining traditional Chinese and Western medicine treatment (1) Screening for individuals who have received interferon standardized treatment within the first six months (standardized treatment is defined as continuous use of interferon for more than 3 months). (2) Patients with compensated and decompensated cirrhosis of type B: including those with a clear history of cirrhosis (imaging or histological evidence) or a Child Pugh score = 5 before antiviral treatment with nucleoside (acid) drugs or those who have experienced complications such as ascites hepatic encephalopathy esophageal and gastric variceal rupture and bleeding during decompensated cirrhosis of the liver. (3) Primary liver cancer or those with imaging indications of liver malignancy during screening. (4) Merge with other malignant tumor patients (excluding those who have already been cured). (5) Combined with HCV HDV hepatitis virus infection alcoholic liver disease genetic metabolic liver disease and other chronic liver diseases. (6) Neutrophil count<1.5 x 109 cells/L or platelet count<90 x 109 cells/L; creatinine level higher than 1.5 times the upper limit of normal. (7) Individuals who are allergic to interferon and its drug components. (8) Merge autoimmune diseases (including autoimmune liver disease psoriasis etc.) and retinal diseases. (9) Patients with severe diseases of important organs such as heart lungs kidneys brain and blood. (10) Patients with severe neurological and psychiatric disorders (such as depression mania seizures schizophrenia etc. uncontrolled epilepsy). (11) Control unstable diabetes hypertension thyroid disease etc. (12) Pregnant and lactating women with pregnancy planners during the study period. Research Two A randomized controlled trial on the improvement of the reversal rate of viral hepatitis cirrhosis by combining traditional Chinese and Western medicine treatment (1) Suspected of liver cancer. (2) Merge with other liver diseases. (3) Those with Child Pugh classification of C. (4) ALT = 5ULN or AST = 5ULN or Scr = 1.5ULN. (5) Merge other organ dysfunction or malignant tumors. (6) Pregnant and lactating women or those who have recently expressed a desire to have children. (7) Serious mental illness. (8) Participated in clinical trials of other drugs within the first 3 months of screening. Research Three Real world study on the improvement of HBeAg seroconversion rate in NAs treated HBeAg positive CHB patients through integrated traditional Chinese and Western medicine treatment plan Exclusion criteria are the same as the study. Research Four Real world study on the improvement of HBsAg seroconversion rate in NAs treated HBeAg negative CHB patients using a combination of traditional Chinese and Western medicine treatment plan Exclusion criteria are the same as the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hepatitis B e antigen?;Cirrhosis reversal rate;hepatitis b surface antigen(includ dilution); | — |
Secondary
| Measure | Time frame |
|---|---|
| total bilirubin; ?hepatitis B surface antibody?;abnormal prothrombin;hepatitis B e antigen?;Liver Fibroscan;prealbumin;CTP score;APRI Score;alkaline phosphatase;glutamic oxaloacetic transaminase;glutamyl transpeptidase;upper abdominal enhanced MRI;Hepatitis B E antibody;Alpha-fetoprotein;hepatitis B virus ribonucleic acid?;serum albumin;Alanine aminotransferase;hepatitis B core antibody?;FIB4 Index;TCM syndrome scale;MELD score;upper abdominal ultrasound;AFP variant;Incidence rate of end-stage diseases such as liver cirrhosis and liver cancer;Upper abdominal magnetic resonance elastography;Improvement degree of inflammation and fibrosis in liver histology; ?hepatitis B core-related antigen?;Hepatitis B virus Deoxyribonucleic acid(HBV DNA); | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed