A Randomized Controlled Trial on the Treatment of Acute Ischemic Stroke(Syndrome of Yang Obstruction) by Comprehensive Treatment of TCM

Guang'anmen Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) Age =18 and =80, male or female;
•(2) After the onset of the disease, 4=NIHSS=25; The sum of NIHSS fifth and sixth scores =2.
•(3) Onset within 72 hours (including 72 hours);
•(4) Patients who met the diagnostic criteria of ischemic stroke in Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 and had good recovery after the first attack or the last attack (mRS score =1 point before the attack);
•(5) Meet the diagnostic criteria of ischemic stroke in TCM
•(6)Obtain informed consent signed voluntarily by patients or their legal representatives and approved by the ETHICS Committee.

•(1) CT or MRI showed intracranial hemorrhage, epidural hematoma and subdural hematoma;
•(2) CT or MRI indicated large scale cerebral infarction (ASPECT score < 6 points or infarction area > 1/3 of the blood supply area of MCA or infarction volume > 70ml);
•(3) Patients with intracranial hemorrhage after vascularization treatment (such as thrombolysis, thrombectomy, ultra-early thrombus aspiration and stenting);
•(4) Patients with hemorrhagic diseases or bleeding tendency;
•(5) Refractory hypertension beyond drug control was defined as systolic blood pressure > 185mmHg or diastolic blood pressure > 110mmHg;
•(6) Liver function during screening: ALT or AST > 2.0 times the upper limit of normal value; Renal function: serum creatinine (Scr) > 1.5 times the upper limit of normal; Blood glucose < 2.7mmol/L;
•(7) Known severe heart, lung, liver or kidney failure or other serious diseases (such as untreated intracranial tumor, encephalitis, brain abscess, severe pneumonia, etc.);
•(8) APACHEII score > 25;
•(9) life expectancy < 90 days or unable to complete 90±14 days follow-up;
•(10) patients with mental diseases;
•(11) pregnant or lactating women;
•(12) allergic to the test drug ingredients;
•(13) Participants in clinical trials of other drugs or devices who have not completed the primary study endpoint;
•(14) Other conditions that the investigator judged inappropriate for inclusion.

发起方