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

Not Applicable

• Conditions: Acute ischemic stroke

• Registration Number: ITMCTR2200005939
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mRS score;

Secondary Outcome Measures

Name	Time	Method
BI score;UA;IL-6;NIHSS score;GCS score;Evaluation index of TCM syndrome and symptom efficacy;Blood coagulation function;Hcy;Cys C;CPR;TNF-a;