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Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Primary Purpose

Acute Stroke, Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xingnaojing injection
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Stroke

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Expected length of hospital stay is less than 10 days;
  • Planned or already receiving intravenous thrombolysis or endovascular treatment;
  • Use of drugs with unknown composition within 1 week before enrollment;
  • Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
  • 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;
  • Currently receiving an investigational drug.

Sites / Locations

  • Dongzhimen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Xingnaojing injection

Standard care

Arm Description

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care

Subjects will receive guidelines-based standard care. Interventions: Other: Standard care

Outcomes

Primary Outcome Measures

The change of NIHSS score
The NIHSS score ranges from 0 (best score) to 42 (worst score).

Secondary Outcome Measures

The proportion of NIHSS score from 0 to 1
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Patient reported outcome (PRO) scale of stroke
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
The proportion of patients independent at 30 days and 90 days
The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).
Cardio-cerebral vascular incident
Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.
The difference in proteomic and metabolomics
Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.（It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.）
State of consciousness
The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Activities of daily living
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Safety end points
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Stroke related deaths and deaths from any cause
Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.

Full Information

First Posted
March 16, 2021
Last Updated
February 17, 2022
Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Affiliated Hospital of Nantong University, Nanjing Brian Hospital, Affiliated Hospital of Chengde Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04813445
Brief Title
Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke
Official Title
Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Anticipated)
Study Completion Date
September 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Affiliated Hospital of Nantong University, Nanjing Brian Hospital, Affiliated Hospital of Chengde Medical University

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 purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.
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. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . 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. The primary outcome will be determined at 11 days.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xingnaojing injection
Arm Type
Experimental
Arm Description
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Subjects will receive guidelines-based standard care. Interventions: Other: Standard care
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 10 days.
Primary Outcome Measure Information:
Title
The change of NIHSS score
Description
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame
Baseline, 3 days, 7 days and 10 days
Secondary Outcome Measure Information:
Title
The proportion of NIHSS score from 0 to 1
Description
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame
Baseline, 3 days, 7 days and 10 days
Title
Patient reported outcome (PRO) scale of stroke
Description
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
Time Frame
10 days
Title
The proportion of patients independent at 30 days and 90 days
Description
The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).
Time Frame
30 days and 90 days
Title
Cardio-cerebral vascular incident
Description
Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.
Time Frame
Within baseline and 90 days
Title
The difference in proteomic and metabolomics
Description
Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.（It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.）
Time Frame
baseline (pre-dose), 7 days and 11days
Title
State of consciousness
Description
The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Time Frame
Baseline, 3 days, 7 days and 10 days
Title
Activities of daily living
Description
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Time Frame
30 days and 90 days
Title
Safety end points
Description
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Time Frame
10 days
Title
Stroke related deaths and deaths from any cause
Description
Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.
Time Frame
Within 10 days and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of Acute ischemic stroke； Symptom onset within 24 hours； 35 ≤ Age ≤ 80 years； 4 ≤ NIHSS ≤ 25； Patient or legally authorized representative has signed informed consent. Exclusion Criteria: Expected length of hospital stay is less than 10 days; Planned or already receiving intravenous thrombolysis or endovascular treatment; Use of drugs with unknown composition within 1 week before enrollment; Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group; 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; Currently receiving an investigational drug.
Facility Information:
Facility Name
Dongzhimen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Gao, MD
Phone
0086-010-84013209
Email
gaoying973@126.com
First Name & Middle Initial & Last Name & Degree
Ping Jiang, MD
Phone
0086-18810923089
Email
18810923089@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

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