Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke
NCT ID: NCT04946474
Last Updated: 2021-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
520 participants
INTERVENTIONAL
2019-06-01
2021-09-01
Brief Summary
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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
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Xingnaojing 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 ).
Xingnaojing 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 ).
Placebo group
Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.
Xingnaojing 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 ).
Interventions
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Xingnaojing 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 ).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking Yniversity Third Hospital
Beijing, , China
Countries
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Other Identifiers
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M2019412
Identifier Type: -
Identifier Source: org_study_id