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

NCT04946474 | Unknown Phase 4

• 1 other identifier: M2019412
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• self-care

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

  after 90 days

Secondary Outcomes (1)

• NIHSS

  on day 14 of onset

Study Arms (2)

Xingnaojing injection + Shuxuetong oral liquid

EXPERIMENTAL

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 group

PLACEBO COMPARATOR

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

Drug: Xingnaojing injection + Shuxuetong oral liquid

Interventions

Xingnaojing injection + Shuxuetong oral liquid DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Peking Yniversity Third Hospital

Beijing, China

Location

MeSH Terms

Interventions

xingnaojing

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)