Chronic hepatitis B virus liver fibrosis (liver stagnation and spleen deficiency combined with blood stasis and collateral obstruction syndrome)
Conditions
Interventions
High dose:During the 48th week of the treatment period, take basic medication + Huangjia Ruangan granules, 10g/bag, take with warm water in the morning and evening, 1 bag/time, 2 times/day.
Basic medi
Low dose:During the 48th week of the treatment period, take basic medication + Huangjia Ruangan Granules, 10g/bag, take with warm water in the morning, 1 bag/time, 1 time/day + Huangjia Ruangan Granul
Placebo control group :During the 48th week of the treatment period, take basic medication + Huangjia Ruangan granule simulation agent, 10g/bag, take with warm water in the morning and evening, 1 bag/
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: 1. Age at the time of informed consent is 18-65 years old (including 18 and 65 years old), gender is not limited; 2. Meet the diagnostic criteria for chronic hepatitis B virus; 3. The pathological results of liver tissue biopsy meet the Ishak diagnostic criteria for liver fibrosis, and the stage is stage 2-5; 4. Comply with the TCM syndrome differentiation standard of liver stagnation and spleen deficiency combined with blood stasis and collateral obstruction; 5. The subjects are treatment-naive patients who are taking entecavir for the first time (HBeAg-positive patients, HBV-DNA = 20000 IU/ml (equivalent to 105 copies/ml); HBeAg-negative patients, HBV-DNA = 2000IU/ml ( Equivalent to 104 copies/ml)) or those who have been using entecavir for more than 1 year and whose HBV-DNA is lower than the lower limit of detection; 6. Female subjects of childbearing potential (amenorrhea women aged =50 years are also considered to be of childbearing potential) with negative urine pregnancy test, subjects of childbearing age (including male subjects with heterosexual sex and those with childbearing potential) Potential female partners have no pregnancy plans within 6 months from the screening period to cessation of medication and voluntarily take effective contraceptive measures; 7. Voluntarily participate in this clinical trial and be able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Received IFN-based anti-HBV treatment within 6 months before screening; 2.Systemic use of potent immunomodulators such as adrenocorticoids, thymosin alpha, etc. for more than 2 weeks within 6 months before screening or in anticipation that such drugs will be used during the study, but corticosteroid nasal sprays, inhaled steroids, and/or topical Treatments such as steroids are excluded; 3.Evidence showing decompensation of liver function, including but not limited to: TBIL >5 times ULN or prothrombin activity (PTA) upper limit of normal value); 11.Routine blood white blood cell (WBC) count 8.5% confirmed by retest); 13.Mental and neurological diseases, including those with a history of mental illness or a family history of mental illness; 14.Severe cardiovascular disease: uncontrolled hypertension (systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg), New York Heart Association (NYHA) class III and above, myocardial infarction within 6 months before screening, 6 months before screening Intracoronary angioplasty and unstable angina within months; 15.During the screening period, electrocardiogram results showed QTc interval (QTcF or QTcB) = 500 ms or uncontrolled arrhythmia such as II° or III° atrioventricular block; 16.Past severe hematological diseases (various severe anemias, hemophilia, etc.); 17.Previous severe kidney disease (chronic kidney disease, renal insufficiency, etc.); 18.Severe digestive system diseases in the past (refractory peptic ulcer, refractory colitis, etc.); 19.Previous severe respiratory diseases (active pulmonary tuberculosis, severe lung infection, etc.); 20.Active or suspected malignant tumors or history of malignant tumors within 5 years before screening (except basal cell carcinoma of the skin or carcinoma in situ of the cervix); 21.History of major functional organ transplantation; 22.Those with allergies or a history of severe allergies, especially those allergic to test drugs and ingredients; 23.Long-term heavy drinking (standard for long-term heavy drinking: ethanol equivalent amount: male = 40g/d, female = 20g/d, or a history of heavy drinking within 2 weeks, ethanol equivalent amount 80g/d) and/or psychoactive substances, drugs abusers and dependents; 24.Women who are pregnant or breastfeeding; 25.Those who must use prohibited drugs specified in this trial; 26.Participated in other drug clinical trials within 3 months befor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver histological changes;Fibroscan examination;liver function;APRI score: Aspartate aminotransferase (AST) and platelet (PLT) ratio index, APRI? (AST/ULN***) × 100/PLT (109/L);FIB-4 index: FIB-4?(age×AST)/(platelet×square root of ALT);Serum liver fibrosis markers;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactYue Qiu Gao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed