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

Primary Purpose

Acute Hemorrhagic Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xingnaojing injection + Shuxuetong oral liquid
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hemorrhagic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking Yniversity Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xingnaojing injection + Shuxuetong oral liquid

Placebo group

Arm 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 ).

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

Outcomes

Primary Outcome Measures

self-care
90 days of self-care (mRS 0-2 points)

Secondary Outcome Measures

NIHSS
NIHSS score improvement on day 14 of onset

Full Information

First Posted
June 27, 2021
Last Updated
June 27, 2021
Sponsor
Peking University Third Hospital
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04946474
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hemorrhagic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xingnaojing injection + Shuxuetong oral liquid
Arm Type
Experimental
Arm 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 ).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.
Intervention Type
Drug
Intervention Name(s)
Xingnaojing injection + Shuxuetong oral liquid
Intervention 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 ).
Primary Outcome Measure Information:
Title
self-care
Description
90 days of self-care (mRS 0-2 points)
Time Frame
after 90 days
Secondary Outcome Measure Information:
Title
NIHSS
Description
NIHSS score improvement on day 14 of onset
Time Frame
on day 14 of onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 > 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.
Facility Information:
Facility Name
Peking Yniversity Third Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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