The clinical accurate localization of Salvianolic Acids for Injection in the treatment of ischemic cerebrovascular disease inacute stage - a multi-center, single-arm, open clinical protocol.
- Conditions
- acute Ischemic stroke
- Registration Number
- ITMCTR2200005489
- Lead Sponsor
- Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Ischemic stroke onset in the preceding 72 hours
2.National Institutes of Health Stroke Scale 6 to 20(including the boundary value)
3.Males and females aged 18 years or older
4.First onset or historical stroke without sequela and mRS score <= 1
5.Sign the informed consent.
1. Cranial imaging confirmed brain tumor, encephalitis, brain abscess and other diseases with similar symptoms, or confirmed hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage. 2. Severe disturbance of consciousness(NIHSS Ia >=2)3.Allergic to the drug ingredients used in the study. 4. Patients with severe primary diseases of heart, liver, kidney, blood and endocrine system. 5. Pregnant and lactating women. 6. Drug or alcohol abuser. 7. Mentally ill. 8. Participants who are participating in or have participated in other clinical trials within a month. 9. The researchers did not consider the selected subjects appropriate.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Rankin Scale;
- Secondary Outcome Measures
Name Time Method MMSE;Metabonomics;Barthel index;The incidence of MACCE;NIHSS;The incidence of apoplexy-related complications;