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| Name | Class |
|---|---|
| Tianjin University of Traditional Chinese Medicine | OTHER |
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The aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xueshuantong | Experimental | Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care. |
|
| Placebo | Placebo Comparator | Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xueshuantong lyophilized powder | Drug | Xueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline | The aim is to assess the effects of Xueshuantong lyophilized powder versus placebo on reducing the neurological impairment when initiated within 72 hours of symptom onset in patients with acute ischemic stroke. The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. | Day 10 ± 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment) | The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline | Level of intercellular adhesion molecule 1 is associated with the clinical outcome. | Day 10 ± 2 |
| Change in Interleukin 6 level on day 10 (after the treatment) from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Gao | Contact | 0086-010-84013209 | gaoying973@126.com | |
| Luda Feng | Contact | (+86)13051528128 | luda_feng@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Drug | Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group. |
|
| Guidelines-based standard care | Other | Guidelines-based standard care for acute ischemic stroke |
|
| Day 10 ± 2 |
| Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment) | Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst). | Day 10 ± 2 |
| The proportion of patients with modified Rankin Scale grade ≤1 on day 90 | Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS grade between 3 to 6 points are considered to be poor functional outcome. | Day 90 ± 7 |
| The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90 | Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best). | Day 90 ± 7 |
| Quality of life of patients measured by Stroke-specific quality of life scale on day 90 | Stroke-Specific Quality of Life Scale is a standardized instrument for evaluating health-related quality of life. The score of 49-item scale with 12 domains range from 49 (worst) to 245 (best). | Day 90 ± 7 |
| Incidence of treatment-related adverse events | Number of patients with any adverse events during the study. | Up to Day 90 |
Level of Interleukin 6 is associated with the clinical outcome. |
| Day 10 ± 2 |
| Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline | Level of tumor necrosis factor-α is associated with the clinical outcome. | Day 10 ± 2 |
| Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline | Level of matrix metalloproteinase 9 is associated with the clinical outcome. | Day 10 ± 2 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |