search
Back to results

Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH)

Primary Purpose

Ischemic Stroke, Acute

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xingnaojing injection
Sponsored by
Ying Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemic Stroke, Acute

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Acute ischemic stroke；
  • Symptom onset within 24 hours；
  • 40 ≤ age ≤ 80 years;
  • 4 ≤ NIHSS ≤ 25；
  • Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Planned or already receiving intravenous thrombolysis or endovascular treatment;
  • Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
  • Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
  • Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
  • Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
  • Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
  • Other conditions that render outcomes or follow-up unlikely to be assessed;
  • Known to be pregnant or breastfeeding;
  • Use any drugs containing traditional Chinese medicine within 1 week before enrollment;
  • Currently receiving an investigational drug.

Sites / Locations

  • Beijing Chaoyang Integrative Medicine Rescue and First Aid HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Xingnaojing injection group

Standard care group

Arm Description

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drugs:Xingnaojing injection Other: Standard care (eg. antiplatelet drugs and statins)

Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (eg. antiplatelet drugs and statins)

Outcomes

Primary Outcome Measures

Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at baseline.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 6 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 6 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 7 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 8 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 8 days.

Secondary Outcome Measures

The change of neurological deficits
The change of neurological deficits is measured by the change of National Institute of Health Stroke Scale (NIHSS) score, ranging from 0 (best score) to 42 (worst score).
Patient reported outcome
Patient reported outcome is measured by Patient reported outcome (PRO) scale of stroke, ranging from 0(worst score) to 180 (best score).
The proportion of life dependency
The proportion of life dependency is defined as Modified Rankin Scale (mRS) score 0-2. The mRS score ranges from 0 (best score) to 6 (worst score).
The degree of disability
The degree of disability is measured by the distribution proportion of mRS score, ranging from 0 (best score) to 6 (worst score).
Number of participants with cerebral vascular incidents
Cerebral vascular incidents are defined as stroke, transient ischemia attack, etc.
Number of participants with cardio-cerebral vascular incidents
Cardio-cerebral vascular incidents are defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), etc.

Full Information

First Posted
November 11, 2021
Last Updated
September 24, 2022
Sponsor
Ying Gao
Collaborators
Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05559307
Brief Title
Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke
Acronym
PUBLISH
Official Title
Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH): A Non-randomized, Open-label, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying Gao
Collaborators
Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital

4. Oversight

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

5. Study Description

Brief Summary
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
Detailed Description
Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. In order to further clarify the main pharmacodynamic substances of Xingnaojing in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, open-label, controlled clinical trial. The primary hypothesis is that , compared with the control group, Xingnaojing will produce serial changes in plasma metabolites at baseline (pre-dose) and 7 days, as well as urine metabolites at baseline (pre-dose), 6 days, 7 days and 8 days. The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xingnaojing injection group
Arm Type
Experimental
Arm Description
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drugs:Xingnaojing injection Other: Standard care (eg. antiplatelet drugs and statins)
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (eg. antiplatelet drugs and statins)
Intervention Type
Drug
Intervention Name(s)
Xingnaojing injection
Intervention Description
Xingnaojing injection 20 ml+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 7 days.
Primary Outcome Measure Information:
Title
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline.
Description
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at baseline.
Time Frame
Baseline
Title
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 6 days.
Description
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 6 days.
Time Frame
6 days
Title
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Description
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 7 days.
Time Frame
7 days
Title
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 8 days.
Description
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 8 days.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
The change of neurological deficits
Description
The change of neurological deficits is measured by the change of National Institute of Health Stroke Scale (NIHSS) score, ranging from 0 (best score) to 42 (worst score).
Time Frame
Baseline, 7 days
Title
Patient reported outcome
Description
Patient reported outcome is measured by Patient reported outcome (PRO) scale of stroke, ranging from 0(worst score) to 180 (best score).
Time Frame
7 days
Title
The proportion of life dependency
Description
The proportion of life dependency is defined as Modified Rankin Scale (mRS) score 0-2. The mRS score ranges from 0 (best score) to 6 (worst score).
Time Frame
30 days, 90 days
Title
The degree of disability
Description
The degree of disability is measured by the distribution proportion of mRS score, ranging from 0 (best score) to 6 (worst score).
Time Frame
30 days, 90 days
Title
Number of participants with cerebral vascular incidents
Description
Cerebral vascular incidents are defined as stroke, transient ischemia attack, etc.
Time Frame
90 days
Title
Number of participants with cardio-cerebral vascular incidents
Description
Cardio-cerebral vascular incidents are defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), etc.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Acute ischemic stroke； Symptom onset within 24 hours； 40 ≤ age ≤ 80 years; 4 ≤ NIHSS ≤ 25； Patient or legally authorized representative has signed informed consent. Exclusion Criteria: Planned or already receiving intravenous thrombolysis or endovascular treatment; Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases; Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ; Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease); Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis); Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal); Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer) Other conditions that render outcomes or follow-up unlikely to be assessed; Known to be pregnant or breastfeeding; Use any drugs containing traditional Chinese medicine within 1 week before enrollment; Currently receiving an investigational drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin
Phone
17801222857
Email
qinmz@bucm.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao
Organizational Affiliation
Dongzhimen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu
Phone
18182538201

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke

We'll reach out to this number within 24 hrs