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

Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Hemorrhagic Stroke
• Intervention / Treatment: Drug: Xingnaojing injection + Shuxuetong oral liquid

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 Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Yniversity Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 ).	Drug: 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 Comparator: Placebo group; Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.	Drug: 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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-care	90 days of self-care (mRS 0-2 points)	after 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS	NIHSS score improvement on day 14 of onset	on day 14 of onset

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: M2019412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No