ITMCTR2000002982已完成2 期
A randomized, double-blinded, parallel-controlled, dose exploratory, multicentered-phase II clinical trial for the safety and effectiveness of hydroxysafflor yellow A (HSYA) injection in the treatment of&
Guangdong Hospital of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 性别
- All
入选标准
- •(1) Meet the diagnosis standard of stroke in traditional Chinese medicine and the diagnosis standard of blood stasis syndrome, western medicine diagnosed as atherosclerotic thrombotic cerebral infarction;
- •(2) Apoplexy was divided into acute stage and middle meridian patients;
- •(3) NIHSS score of neurological deficit 7 to 22;
- •(4) The patients were anterior circulation infarction;
- •(5) This is the first stroke, no previous history of stroke;
- •(6) The course of disease should be within 7 days;
- •(7) Aged 35-75 years male and female;
- •(8) After the onset of the disease, the patients had not been treated with intravenous thrombolysis, arterial thrombectomy or stenting;
- •(9) Patients or legal guardians who have informed consent to accept the clinical trial and sign the informed consent.
排除标准
- •(1) Hemorrhagic cerebral infarction;
- •(2) Patients with history of atrial fibrillation were considered as cardiogenic cerebral embolism;
- •(3) The prothrombin time, prothrombin time and partial COA time 1.5 ULN, or fibrinogen was less than 1.5g/l, or there was active gastrointestinal bleeding and other bleeding tendency;
- •(4) Patients with heart, liver, kidney, hematopoiesis and serious metabolic system diseases (alt, AST >=1.5 ULN, or bun >=1.2 ULN, Cr > ULN), with cardiac function of grade 3 or above;
- •(5) Pregnant or preparing pregnant and lactating women;
- •(6) Patients with disabilities (blind, deaf, dumb, mental disorders and other causes of physical disability affecting the evaluation of neurological deficit) as prescribed by law;
- •(7) Suspected history of alcohol or drug abuse, or other lesions that, in the judgment of the investigator, reduce or complicate enrollment;
- •(8) Those with allergic constitution (refer to those who are allergic to more than two kinds of drugs or foods or known ingredients of this test drug) or those who are allergic to known ingredients of this drug;
- •(9) Those who have used drugs known to damage the main organs within four weeks;
- •(10) Patients who are participating in other clinical trials or who have participated in other drug clinical trials for less than 1 month;
- •(11) Those who had used safflower and other similar drugs within 2 weeks before inclusion;
- •(12) The patient is unwilling or unable to cooperate or the researcher thinks it is not suitable for clinical trial.
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