Clinical study of Ruyi Zhenbao Tablets and Baimai Ointment in the treatment of acute ischemic stroke: a multi-center, randomized, double-blind, parallel controlled clinical study

Phase 4

• Conditions: Acute Ischemic Stroke

• Registration Number: ITMCTR2000003844
• Lead Sponsor: Xuanwu Hospital, Capital Medical University

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. Subjects aged 18 to 75 years;
2. Patients diagnosed as acute ischemic stroke according to the WHO stroke diagnostic criteria, the onset time is within 7 days (including 7 days), and confirmed by head CT or MRI examination;
3. Patients with large artery atherosclerosis according to toast (trial of Org 10172 acute stroke treatment) classification;
4. NIHSS score: 6-22 points (including 6 points and 22 points), and limb movement item (total score of 5 and 6 items of NIHSS score) >=2 points;
5. Mrs score >=3 and Bi score < 60;
6. Patients with the first onset of the disease, or no obvious sequelae of previous stroke (MRS <=1 before the onset of the disease);
7. Understand and abide by the research process, voluntarily participate in the study, and sign the informed consent form (the informed consent is signed by the person or legal representative voluntarily).

Exclusion Criteria

1. Patients with brain tumor, encephalitis, brain abscess and other diseases with similar symptoms confirmed by cranial imaging examination, or hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
2. Patients with progressive stroke, transient ischemic attack (TIA) and lacunar infarction;
3. The patients with multi lobar infarction (low density > 1 / 3 hemisphere) showed by imaging;
4. Patients who can't know the onset time of stroke symptoms;
5. Patients with hemorrhagic diseases or bleeding tendency, or patients with lower extremity venous thrombosis;
6. The subjects with NIHSS score 1a (consciousness level item) >=2 points at screening;
7. Patients who are ready for or have undergone endovascular therapy;
8. Patients whose hypertension has not been controlled after active antihypertensive treatment. Uncontrolled hypertension was defined as systolic blood pressure > 185mmhg and / or diastolic blood pressure > 110mmhg measured at least 10 minutes interval;
9. Subjects with blood glucose < 50 mg / dl (equivalent to 2.78 mmol / L) or > 400 mg / dl (equivalent to 22.2 mmol / L);
10. Patients with severe cerebral hemorrhage within 3 months with severe abnormal liver and kidney function (ALT or ast greater than 2 times of normal upper limit, creatinine value greater than 1.5 times of normal upper limit);
11. Patients whose expected survival time is less than 1 year due to other diseases;
12. Patients who are known to be allergic to research drugs or similar ingredients, or materials used for imaging examination;
13. Patients who have to take or wish to continue to take the restricted drugs specified in the protocol or any drugs that may interfere with the test results;
14. Patients who have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;
15. Women in pregnancy or lactation, or women with positive pregnancy test results;
16. Patients with mental illness who are unable or unwilling to cooperate;
17. Subjects considered unsuitable for the clinical study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Score;

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with mRS scores 0-2 (including 0 and 2) on the 90th day after the onset;D29 simplified Fugl-Meyer score absolute value;The incidence of cardiovascular and cerebrovascular events on the 90th day after onset;The absolute value of Tibetan medicine stroke symptom classification and quantitative score on the 90th day after onset;On the 90th day after the onset of stroke, the absolute value of the diagnostic score of the Tibetan medicine subdivision of disease elements;D29 NIHSS score absolute value;Proportion of subjects with a Barthel index score >= 95 on the 90th day after onset;