Acute ischemic stroke
Conditions
Interventions
Experimental group:Guidelines based Western Medicine Routine Treatment+Seventy Flavored Pearl Pills
control group:Guidelines based Western Medicine Routine Treatment
Sponsors
Xiyuan Hospital of China Acadeny of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for acute ischemic stroke in Western medicine; 2. Patients within 72 hours after the onset of stroke (appearance of stroke symptoms or signs) ; 3. Patients with first-time or recurrent stroke should have a modified Rankin Scale (mRS) score of 0-1 before the onset of the disease ; 4. Age range from 35 to 80 years old (including boundary values), gender is not limited ; 5. When included, the National Institutes of Health Stroke Scale (NIHSS) score was = 5 and = 15 points ; 6. Patients who voluntarily participate in research, cooperate with examinations and treatments; 7. The patient or family member signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who lack clear diagnostic evidence such as CT or MRI, or whose imaging diagnostic evidence is insufficient to determine the diagnosis; 2. Patients who have been confirmed through previous examinations to have cerebral embolism caused by brain tumors, traumatic brain injury, cerebral parasitic diseases, metabolic disorders, rheumatic heart disease, coronary heart disease, and other heart diseases combined with atrial fibrillation; 3. Clinically considered as transient ischemic stroke, TOAST classified cardioembolic stroke (pre enrollment electrocardiogram indicates atrial fibrillation, and/or history of heart valve disease, atrial fibrillation, etc.), or unexplained ischemic stroke; 4. Those who suffer from other diseases that affect limb mobility, such as those caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which may affect neurological or functional examinations; 5. Other comorbidities and complications that may affect drug evaluation, such as severe congestive heart failure (NYHA grade III or IV), chronic liver dysfunction (ALT, AST>2 times the normal upper limit), renal dysfunction (BUN>1.2 times the normal upper limit, Cr>the normal upper limit), and cerebral hemorrhage after cerebral infarction death; 6. Patients who have received intravenous thrombolysis or endovascular intervention treatment (including mechanical thrombectomy, arterial thrombolysis, and angioplasty); 7. Disabled patients (blind, deaf, mute, intellectually disabled, mentally disabled, physically disabled) as required by law, and those who are unable to understand and/or comply with research procedures due to severe mental, cognitive, or emotional disorders; 8. Individuals with an expected survival time of no more than 3 months, severe stroke or life-threatening serious diseases (such as malignant tumors, serious diseases of the blood, digestive or other systems); 9. Have used the same type of traditional Chinese medicine or traditional Chinese patent medicines and simple preparations within 2 weeks; 10. Those who are known to be allergic to Seventy Flavored Pearl Pills or ingredients, or those with allergic constitution; 11. Pregnant, planned or lactating women; 12. Patients who participated in other clinical trials within the first three months of enrollment; 13. Other situations where the researcher deems it inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of V2-V6 visit point modified Rankin scale (mRS) scores = 1 point;The proportion of Barthel Index (Improved BI) = 90 points for improving daily living ability at the V2-V6 visit point;The proportion of NIHSS scores decreased by = 2 points from baseline at the V2-V6 visit point;The proportion of V2-V6 visit points with a NIHSS score = 1 point;Changes in NIHSS score at V2-V6 visit points compared to baseline;Changes in SS-QOL scores at V2-V6 visit points compared to baseline;The incidence of new vascular events (including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, and vascular death) within 14 days of medication use and 90 days of discontinuation;Readmission rate of patients at V4-V6 visit points; | — |
Countries
China
Contacts
Public Contactsun linjuan
Xiyuan Hospital of China Acadeny of Chinese Medical Sciences
Outcome results
None listed