Acute Hemorrhagic Stroke
Conditions
Brief summary
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage. Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage
Detailed description
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage. Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.
Interventions
DRUGXingnaojing injection + Shuxuetong oral liquid
Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
Sponsors
Beijing Tiantan Hospital
Peking University Third Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ① It meets the diagnostic criteria of primary cerebral hemorrhage. * Within 72 hours of onset. * National Institutes of Health Stroke Scale (NIHSS) score ≥4 points. ④ Glasgow Coma Scale (GCS) score > Eight points. ⑤ Age 18-80. Patient or legal representative informed consent, and sign informed consent.
Exclusion criteria
* (1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic. * The patients with previous stroke history and remaining sequelae affected the outcome assessment, that is, the modified Ranking scale (MRS) score before the onset of stroke was ≥2 points. (3) known by amyloid cerebrovascular disease, vascular malformation, aneurysm, blood coagulation dysfunction, anticoagulation and antiplatelet drug treatment, thrombolysis therapy, bleeding after infarction after conversion, haematology, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, and vascular inflammation caused by clear etiology of patients with cerebral hemorrhage or primary intraventricular hemorrhage. (Note: After anticoagulant or antiplatelet therapy refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-care | after 90 days | 90 days of self-care (mRS 0-2 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS | on day 14 of onset | NIHSS score improvement on day 14 of onset |
Countries
China
Outcome results
None listed