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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ginkgo diterpene lactone meglumine injection | Active Comparator | ginkgo diterpene lactone meglumine injection |
|
| Ginkgo diterpene lactone meglumine injection simulation | Placebo Comparator | Ginkgo diterpene lactone meglumine injection simulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo diterpene lactone meglumine injection | Drug | 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days. | Baseline, 7days | |
| Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yongjun wang, M.D. | Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiantan Hospital | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39548582 | Derived | Tian X, Xu Q, Xia X, Zhang Y, Zhao X, Wang A. Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. Health Qual Life Outcomes. 2024 Nov 15;22(1):99. doi: 10.1186/s12955-024-02315-1. | |
| 37578791 | Derived | Zhang Q, Wang A, Xu Q, Xia X, Tian X, Zhang Y, Li X, Yang X, Wang X, Peng J, Li Y, Liu L, Jin S, Meng X, Zhao X; GDLM group. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828. doi: 10.1001/jamanetworkopen.2023.28828. |
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| Ginkgo diterpene lactone meglumine injection simulation | Drug | 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip. |
|
| Baseline,7 days,14 days, |
| Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 . | 90 days |
| The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days. | Baseline,14 days,90 days |
| The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days. | Baseline,14 days,90 days |
| The all-cause mortality | 90 days |
| Ischemic stroke recurrence rate | 90 days |
| Composite incidence of vascular events | 90 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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