Clinical trial NCT04946474: Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke
Official title: Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Hemorrhagic Stroke
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2021-06-30
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \&gt; 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.

Primary outcomes:
measure: self-care
timeFrame: after 90 days
Secondary outcomes:
measure: NIHSS
timeFrame: on day 14 of onset
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Yniversity Third Hospital
Study officials:
References: