Salvia polyphenolic acid for injection in the treatment of ischemic stroke (convalescence): a multi-center, single-arm, open clinical study
- Conditions
- Ischemic stroke
- Registration Number
- ITMCTR2000003372
- Lead Sponsor
- The Second Affiliated Hospital of Xingtai Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with ischemic stroke (7 days to 3 months, excluding 7 days, including 3 months);
2. Patients with NIHSS score of 4-20 (including boundary value) in neurological deficit degree;
3. Patients aged 18 and above, regardless of gender;
4. The patient suffering from the first disease, or having a history of disease, has no sequelae such as limb paralysis, and does not affect NIHSS score this time, mRS score <= 1;
5. Patients with 2 or more scores of mRS at the time of inclusion;
6. Patients who voluntarily sign informed consent.
1. The patients with brain tumor, encephalitis, brain abscess and other diseases that lead to similar symptoms are confirmed by skull imaging examination, or the patients with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.;
2. Patients who are allergic to the drug ingredients used in the study;
3. Patients with serious primary diseases such as heart, liver, kidney, blood diseases and endocrine system;
4. Pregnant and lactating women;
5. Objects of drug or alcohol abuse;
6. Patients with mental illness;
7. Subjects who are participating in or have participated in other clinical trials within one month;
8. Subjects considered unsuitable by the researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who returned to a 0-1 mRS score 90 days after treatment;
- Secondary Outcome Measures
Name Time Method Proportion of patients who returned to a 0-1 mRS score 28 days after treatment;Adverse events;Changes in NIHSS scores from baseline;Incidence of stroke related complications;Incidence of MACCE;