Acute ischemic stroke
Conditions
Interventions
control group:0.9% saline injection
experimental group:Hydroxysafflor yellow A 75mg
Sponsors
Guangdong Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of acute ischemic stroke in western medicine; 2. Meet the diagnostic criteria of meridional and collateral stroke in traditional Chinese medicine.; 3. When signing the informed consent form, be between 18 and 85 years old (including 18 years old and 85 years old); 4. The first onset, or have previous a history of cerebral infarction without neurological deficits (mRS score =7 points); 8. The informed consent have been signed by the patients or legal guardians before screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, Intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.) suggested by Neuroimaging examinations (CT/MRI), brain tumor, brain trauma, etc.; 2. Subjects clinically considered for cardiogenic cerebral embolism (the ECG showed atrial fibrillation before enrollment, and/or a history of heart valve disease, atrial fibrillation, etc.); 3. Subjects who have received or intend to undergo intravenous thrombolysis or intravascular interventional therapy (including mechanical endovascular thrombectomy, arterial thrombolysis, and angioplasty); 4. Subjects with poor hypertension control, supine systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110 mmHg before the first administration of the test drug; 5. Subjects with severe liver and kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 ULN, and/or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.; serum creatinine > 2.0 ULN, and/or known severe renal insufficiency disease; 6. Subjects with disease that cause physical dysfunction and affect the nerve function examination, such as claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc.; 7. Subjects with other serious life-threatening diseases (malignant tumors, blood, digestive or other serious diseases of the system, etc.), and the expected survival time does not exceed 3 months; 8. Subjects with other mental illnesses who are unable or unwilling to cooperate; 9. Pregnant women, women planning pregnancy or lactating women (childbearing women need to complete a pregnancy test) 10. Subjects with a history of important organ bleeding within one month (such as history of cerebral hemorrhage, gastrointestinal bleeding, etc.); 11. Subjects allergic to safflower and its components, citicoline sodium, or with severe allergies; 12. Subjects with consciousness impairment: Score over 1 point in ?a of NIHSS; 13. Subjects who have used cerebral vasodilators, other neuroprotective agents (except citicoline sodium), drugs to improve cerebral circulation, and any Chinese medicines that have the effect of promoting blood circulation and removing blood stasis or are indicated for the treatment of cerebral infarction, including Chinese medicine yinpian and Chinese patent medicine preparations after the onset; 14. Subjects who is suspected of or did have a history of alcohol or drug abuse; 15. Subjects who have participated in other clinical trials in 3 months, or is participating in other clinical trial 16. Other situations that is considered an inappropriate subject to participate in this research by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS score <= 1 after 90 days of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose NIHSS score decreased by more than 4 points from baseline or decreased to 3 points or less, evaluated at -2 to 0 days, 14 ± 2 days, and 90 ± 7 days;Proportion of patients with mRS score =95 points 90 days after medication;Proportion of subjects with Barthel index >=75 points 90 days after medication; | — |
Countries
China
Contacts
Public ContactYefeng Cai
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed