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

Phase 4

• Conditions: Acute Hemorrhagic Stroke
• Interventions: Drug: Xingnaojing injection + Shuxuetong oral liquid

• Registration Number: NCT04946474
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-07-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xingnaojing injection + Shuxuetong oral liquid	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 + Shuxuetong oral liquid	Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.

Primary Outcome Measures

Name	Time	Method
self-care	after 90 days	90 days of self-care (mRS 0-2 points)

Secondary Outcome Measures

Name	Time	Method
NIHSS	on day 14 of onset	NIHSS score improvement on day 14 of onset

Trial Locations

Locations (1)

Peking Yniversity Third Hospital; 🇨🇳 Beijing, China