Chronic viral hepatitis B with jaundice
Conditions
Interventions
test group:pientzhuang
Control group:Ku Huang granula
Sponsors
BEIJING YOUAN HOSPITAL,CAPITAL MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) It was consistent with the diagnosis of chronic viral hepatitis B; (2) Serum total bilirubin = 1.5 times the upper limit of normal reference value and = 5 times the upper limit of normal reference value; (3) TCM syndrome differentiation is the syndrome of damp-heat internal knot and blood stasis blocking collateral; (4) Age 18-70 years old (including 18 and 70 years old); (5) Voluntarily participate in this clinical trial, give informed consent and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Hepatobiliary diseases of other causes suspected by history and laboratory tests, including, but not limited to, hepatitis combined with other hepatophilic viral infections such as hepatitis A, hepatitis C, hepatitis D, and hepatitis E, severe nonalcoholic steatohepatopathy, autoimmune hepatitis, alcoholic hepatopathy, drug-induced hepatitis, and related disorders that are predominantly characterized by elevated indirect bilirubin; (2) Patients with primary biliary cirrhosis and cholestatic jaundice due to biliary obstruction; (3) Those whose liver biopsy results showed cirrhosis within the last 1 year; (4) Abnormal liver function and coagulation function caused by other factors; (5)Model for End-stage Liver Disease (MELD) score > 12, or liver Functional Child-Turcotte-Pugh(CTP) score > 6; (6) Excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening (average daily consumption of more than 30 grams of ethanol, equivalent to 3.75 units of alcohol, for men and more than 20 grams, equivalent to 2.5 units of alcohol, for women: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); (7) Patients had ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or previous liver transplantation at the time of randomization or were scheduled to undergo liver transplantation; (8)Hypertension is poorly controlled after treatment (=160/100mmHg); (9) A myocardial infarction, unstable angina had occurred within 6 months before screening, or coronary intervention (diagnostic angiography was allowed) or vascular grafting had occurred within 6 months before screening or New York Heart Association (NYHA) class III or higher; (10) Combined with serious primary diseases of the blood system (various severe anemia, hemophilia, etc.), kidney diseases (chronic kidney disease, renal insufficiency, etc.), respiratory system (active tuberculosis, severe pulmonary infection, etc.), digestive system (active gastrointestinal ulcer, refractory colitis, etc.), nervous system, and mental illness (including history of mental illness or family history of mental illness); (11) Being treated with anticoagulant drugs (e.g., warfarin, heparin, etc.); (12) Presence of the following abnormal laboratory tests: ? eGFR 10 times ULN; (13) HIV positive; (14) Hypersensitivity to the test drug, the base drug, or its components, or a history of severe allergy; (15) Pregnant or lactating women, and subjects of childbearing potential who are unwilling or unable to use effective contraception from the time of screening until 3 months after discontinuation of the investigational drug; (16) Participated in other drug clinical trials as a subject within 3 months; (17) The investigator considers the patients unfit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in total bilirubin (TBIL) from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total bilirubin (TBIL) normalization rate;Evaluation of the efficacy of disease;Time and rate of jaundice disappearance;TCM syndrome curative effect;The change and normalization rate of liver function indexes from baseline;Changes in HBV DNA from baseline;Changes in serum HBeAg, HBeAb, and HBcAb-IgM from baseline; | — |
Countries
China
Contacts
Public ContactXiuhui Li
BEIJING YOUAN HOSPITAL,CAPITAL MEDICAL UNIVERSITY
Outcome results
None listed