The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Xingnaojing injection 20 ml+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 7 days.
Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
Beijing, China
RECRUITINGDifferences 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 days
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).
Time frame: Baseline, 7 days
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).
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Time frame: 7 days
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).
Time frame: 30 days, 90 days
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).
Time frame: 30 days, 90 days
Number of participants with cerebral vascular incidents
Cerebral vascular incidents are defined as stroke, transient ischemia attack, etc.
Time frame: 90 days
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.
Time frame: 90 days