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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04946474

Collaborator

Beijing Tiantan Hospital (Other)

520

Enrollment

Location

Arms

Anticipated Duration (Months)

19.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Hemorrhagic Stroke	Drug: Xingnaojing injection + Shuxuetong oral liquid	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

520 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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 ).

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

Placebo Comparator: Placebo group

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

Drug: Xingnaojing injection + Shuxuetong oral liquid

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

NIHSS [on day 14 of onset]
NIHSS score improvement on day 14 of onset

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Yniversity Third Hospital	Beijing		China

Sponsors and Collaborators

Peking University Third Hospital
Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04946474

Other Study ID Numbers:

M2019412

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Hemorrhagic Stroke

Study Results

No Results Posted as of Jun 30, 2021