Chronic Hepatitis B
Conditions
Interventions
control group:Silybin Capsules + Antiviral therapy
experimental group:Wulingdan Capsules + Antiviral therapy
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Those who have signed the informed consent form; 2)Male or female subjects aged 18–65 years; 3)Subjects whose clinical diagnosis in Western medicine conforms to chronic hepatitis B; 4)Subjects with syndrome differentiation in traditional Chinese medicine (TCM) as hepatobiliary damp-heat syndrome; 5)Subjects with positive serum HBsAg, persistently negative HBeAg, accompanied by positive HBeAb, and positive HBV DNA; 6)Subjects with alanine transaminase (ALT) > 1 ULN and ALT < 10 ULN, and serum total bilirubin (TBIL) < 5 mg/dl (85.5 µmol/L); 7)Subjects with serum albumin (ALB) = 33 g/L; 8)Subjects who have not used any Chinese or Western medicines with definite enzyme-lowering effects within the past 10 days.
Exclusion criteria
Exclusion criteria: 1) Subjects with concurrent infections by other viruses besides hepatitis B virus; 2) Subjects with complicated severe or end-stage liver diseases such as other chronic severe hepatitis, liver cirrhosis, or liver cancer; 3) Subjects with severe primary diseases of the heart, kidneys, lungs, etc., or those with mental illness; 4) Pregnant women, lactating women, or those using estrogen for contraception; 5) Alcohol abusers or drug addicts; 6) Subjects who are unable to cooperate; 7) Subjects with known allergies to the trial drugs; 8) Other severe conditions that may hinder the conduct of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase, ALT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aspartate aminotransferase, AST;Total Bilirubin, TBil;Direct Bilirubin, DBil;Serum Total Protein, TP;Serum albumin, ALB;Traditional Chinese Medicine Syndrome Score;HBV DNA;Hepatitis B e antigen, HBsAg;Hepatitis B surface antibody, HBsAb;Hepatitis B e antigen, HBeAg;Hepatitis B e antibody, HBeAb;Hepatitis B core antibody, HBcAb;Liver stiffness measurement, LSM; | — |
Countries
China
Contacts
Public ContactHuaqiang Zhai
School of Chinese Materia Medica, Beijing University of Chinese Medicine
Outcome results
None listed