Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke

Peking University

Status and phase: Unknown; Phase 4

Conditions: Acute Hemorrhagic Stroke

Treatments: Drug: Xingnaojing injection + Shuxuetong oral liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT04946474

M2019412

Details and patient eligibility

About

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

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups, including a placebo group

Xingnaojing injection + Shuxuetong oral liquid

Experimental group

Description:

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 ).

Treatment:

Drug: Xingnaojing injection + Shuxuetong oral liquid

Placebo group

Placebo Comparator group

Description:

Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.

Treatment:

Drug: Xingnaojing injection + Shuxuetong oral liquid