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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental | Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days |
|
| Medium-dose group | Experimental | Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days |
|
| High-dose group | Experimental | Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days |
|
| Control group | Active Comparator | Edaravone Injection,30 mg/dose, one dose every 12 hours, continues for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Edaravone Injection | Drug |
| ||
| Edaravone Injection |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score on day 90 | day 90 | |
| Change from baseline NIHSS score on day 14 | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 | day 14, 30, 90 | |
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 | day 14, 30, 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital of The Chinese PLA | Beijing | Beijing Municipality | 100048 | China | ||
| Beijing Tiantan Hospital affiliated to Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31709115 | Derived | Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep. |
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| Drug |
|
| The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | day 14, 30, 90 |
| Stroke Impact Scale (SIS) score on day 90 | day 90 |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| The First Affiliated Hospital of Third Military Medical University of Chinese PLA | Chongqing | Chongqing Municipality | 400038 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050051 | China |
| The Second Affiliated Hospital of Haerbin Medical University | Haerbin | Heilongjiang | 150001 | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | 410005 | China |
| Central Hospital of Baotou | Baotou | Inner Mongolia | 014040 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | 221006 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| The General Hospital of Shenyang Military, Chinese PLA | Shenyang | Liaoning | 110016 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| The Second Hospital of Shandong University | Jinan | Shandong | 250033 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266011 | China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| The Second Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| 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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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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