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| Name | Class |
|---|---|
| Affiliated Hospital of Nantong University | OTHER |
| Nanjing Brian Hospital | OTHER |
| Affiliated Hospital of Chengde Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xingnaojing injection | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care |
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| Standard care | No Intervention | Subjects will receive guidelines-based standard care. Interventions: Other: Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xingnaojing injection | Drug | Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| The change of NIHSS score | The NIHSS score ranges from 0 (best score) to 42 (worst score). | Baseline, 3 days, 7 days and 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of NIHSS score from 0 to 1 | The NIHSS score ranges from 0 (best score) to 42 (worst score). | Baseline, 3 days, 7 days and 10 days |
| Patient reported outcome (PRO) scale of stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000594497 | xingnaojing |
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Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
| 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). | 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. | 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.) | baseline (pre-dose), 7 days and 11days |
| 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). | 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). | 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). | 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. | Within 10 days and 90 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |