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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
72
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Dongzhimen Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe change of NIHSS score
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time frame: Baseline, 3 days, 7 days and 10 days
The proportion of NIHSS score from 0 to 1
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time frame: Baseline, 3 days, 7 days and 10 days
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).
Time frame: 10 days
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).
Time frame: 30 days and 90 days
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.
Time frame: Within baseline and 90 days
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.）
Time frame: baseline (pre-dose), 7 days and 11days
State of consciousness
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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
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).
Time frame: 30 days and 90 days
Safety end points
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
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.
Time frame: Within 10 days and 90 days