Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the western medical diagnostic criteria for CHB and refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) formulated by the Hepatology Branch and Infectious Diseases Branch of the Chinese Medical Association to formulate the diagnostic criteria for CHB. 2. Meet the Chinese traditional medicine identification criteria for CHB and refer to the Expert Consensus on Integrated Chinese and Western Medicine Diagnosis and Treatment of Chronic Hepatitis B (2024 Edition) formulated by the Hepatology Expert Committee of Chinese and Western Medicine Combined Medical Practitioners Branch of Chinese Medical Doctors' Association to formulate the identification criteria for CHB with liver-gallbladder and damp-heat syndrome. Primary symptoms: (1) distension and pain in the abdomen and ribs; (2) red tongue with yellowish fur. Secondary symptoms: dullness and vomiting aversion to oil and grease; sticky and foul-smelling stools; yellow urine; yellow body and eyes. Requirements for identification: (1) The syndrome is defined as having two of all the primary symptoms; (2) The syndrome is defined as having one of the primary symptoms plus two of the secondary symptoms. 3. Age 18-65 years old regardless of gender. 4. CHB patients with non-cirrhotic decompensated liver disease who have not received treatment or who have discontinued nucleotide analog therapy for at least 6 months or interferon for at least 1 year before screening. 5. HBV DNA of patients with HBeAg-negative disease =2×104 IU/kg and HBV DNA of patients with HBV DNA =2×104 IU/kg; ALT less than 5 times the upper limit of normal. 6. Informed consent and signing of an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other chronic viral hepatitis hepatocellular carcinoma hepatic encephalopathy or cardiovascular hepatic renal hematopoietic system and other serious diseases psychiatric patients; 2. Patients who are allergic to allergy or allergic to the known components of this drug or other drugs history of drug liver damage; 3. Pregnant women lactating women and women who are preparing for pregnancy; 4. Patients with immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis B virus DNA level;Traditional Chinese medicine syndrome scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Prothrombin Time Activity;Prealbumin;Hepatitis B e antigen level;Aspartate aminotransferase;Alkaline phosphatase;Gamma-glutamyltransferase;Alanine aminotransferase; | — |
Countries
China
Contacts
The Fourth Peoples Hospital of Huaian