ITMCTR2000003533尚未招募4 期
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.
Shuguang Hospital Affiliated With Shanghai University of TCM0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 16 至 65（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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
研究者
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