To evaluate the efficacy and safety of Pien Tze Huang in the treatment of hepatic fibrosis in patients with chronic viral hepatitis B (stagnant blood blocking collateral-damp-heat syndrome): a multicenter, randomized, double-blind, placebo-controlled clinical trial.
- Conditions
- iver fibrosis in chronic viral hepatitis B
- Registration Number
- ITMCTR2000003533
- Lead Sponsor
- Shuguang Hospital Affiliated With Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for liver fibrosis of chronic viral hepatitis B;
(2) The pathological results of liver biopsy in the first 6 months were in line with Ishak diagnostic criteria for liver fibrosis, and the stages were 2-5;
(3) Subjects who have been treated for the first time with entecavir (HBV-DNA positive test) or who have been treated with entecavir for more than 1 year and have HBV-DNA lower than the lower limit of test;
(4) It conforms to the TCM syndrome differentiation standard of blood stasis, collaterals and unexhausted dampness-heat syndrome;
(5) Age form 18 years to 65 years (including 18 and 65) at the time of informed consent, regardless of gender;
(6) Participate in this clinical trial voluntarily, give informed consent and sign informed consent.
(1) 6 months before Screening for interferon-based anti-HBV therapy;
(2) 6 months before Screening for systemic use of immunomodulators such as adrenocorticosteroids, thymosin, etc. for more than 2 weeks or expected during the study period, with the exception of corticosteroid nasal spray, inhaled steroids, and/or topical steroids;
(3) Evidence of liver function decompensation, including but not limited to: TBIL>5 times ULN or prothrombin activity (PTA) < 60% confirmed by retest; Past or present ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy; Previous or existing Child-pugh Class B or C (see Annex 1);
(4) Patients with primary liver cancer, high-risk population of primary liver cancer (family history of liver cancer, liver imaging examination with nodules, etc.), AFP >upper limit of normal reference value;
(5) Patients with hepatitis A, C, D, E and other hepatitis virus infections, severe non-alcoholic fatty liver disease, autoimmune hepatitis, alcoholic liver disease, drug hepatitis, Wilson disease and hematopathy;
(6) Failure of liver puncture or non accurate reading of liver tissue pathology;
(7) ALT >= 5 times ULN and/or AST >= 5 times ULN, or serum creatinine (Scr) > upper limit of normal reference value;
(8) Poorly controlled diabetes (HbA1c > upper limit of normal reference value);
(9) Hypertension of poorly controlled blood pressure after treatment with drug specification (poorly controlled systolic blood pressure or greater 160 mmHg and/or diastolic blood pressure, 100 mmHg or higher), New York, cardiac function class (NYHA) III and above (see annex 2), 6 months before screening happened myocardial infarction and unstable angina, or line within six months of coronary artery intervention treatment or vascular transplantation performer;
(10) Screening ECG examination results QTc (QTcF or QTcB) >= 500 ms or II-III degree atrioventricular block and other uncontrolled arrhythmias;
(11) HIV-infected persons;
(12) Routine blood count: WBC < 3 * 10^9/L, neutrophil (NEUT) < 1.5 * 10^9/L, platelet (PLT) < 50 * 10^9/L or hemoglobin (Hb) < 100g/L;
(13) With severe blood system (all kinds of severe anemia, hemophilia, etc.), kidney disease(chronic kidney disease, kidney function not entire), respiratory system (active tuberculosis, severe lung infection, etc.), the digestive system (refractory digestive ulcer, the refractory colitis, etc.), nervous system, such as the primary disease and mental illness patients (including a history of mental illness or a family history of mental illness).
(14) Long-term heavy drinking (long-term heavy drinking standard: drinking more than 5 years, equivalent to alcohol amount: male >= 40g/d, female >= 20g/d, or history of heavy drinking within 2 weeks, equivalent to alcohol amount > 80g/d) (conversion formula of alcohol amount (g): alcohol amount (m1) * ethanol content (%) * 0.8) and/or psychoactive substances, drug abusers and dependants;
(15) Active or suspected malignant tumor or history of malignant tumor within 5 years prior to screening (excluding basal cell carcinoma of skin or carcinoma in situ of cervix);
(16) A history of transplantation of major functional organs (such as liver, kidney, lung, heart);
(17) Failures are determined by Fibroscan, which is caused by obesity and narrow intercostal space.
(18) Allergic constitution or history of severe allergy, especially allergic to experimental drugs and ingredients;
(19) Pregnant or lactating women, subjects
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of liver function after treatment compared with baseline;Urinary routine;Hemoglobin a1c;Second liver 5;Serum markers of liver fibrosis;AFP;12-lead electrocardiogram;Adverse events;Changes of LSM after treatment compared with baseline;Routine blood test;Fasting plasma glucose;Prothrombin activity;renal function;Abdominal ultrasound;Conventional stool;HBV-DNA;Pathological changes of liver tissue after treatment;Anti-hav, anti-HCV, anti-HDV, Anti-hev, anti-HIV;liver function;Pregnancy test;
- Secondary Outcome Measures
Name Time Method Curative effect of TCM Syndrome;Changes of FIB-4 after treatment compared with baseline;Changes of APRI after treatment compared with baseline;