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| Name | Class |
|---|---|
| China Food and Drug Administration | OTHER_GOV |
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The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danhong injection | Experimental | Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours. |
|
| placebo | Placebo Comparator | Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danhong injection | Drug | A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale 0-1 (favourable outcome) at Day 90 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome) | Day 0, Day7, Day 14, Day 30, Day 60, Day 90 | |
| Barthel Index score ≥90 | Day 0, Day7, Day 14, Day 30, Day 60, Day 90 | |
| Measure | Description | Time Frame |
|---|---|---|
| The changes on the profiles of micro-RNA in 96 patients selected from certain centers | Day 0, Day 14, Day 90 | |
| The changes on the expression profiles of mRNA in 96 patients selected from certain centers | Day 0, Day 14, Day 90 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhong Wang, Professor | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
| Xing-quan Zhao, Professor | Beijing Tiantan Hospital | Principal Investigator |
| Yong-yan Wang, Professor | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Chair |
| Xiao-xi Du, Professor | China Food and Drug Administration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Artillery General Hospital of Chinese People's Liberation Army | Beijing | Beijing Municipality | 100088 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26654631 | Derived | Li B, Wang Y, Lu J, Liu J, Yuan Y, Yu Y, Wang P, Zhao X, Wang Z. Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial. Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4. |
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| Standard medical care | Procedure | Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care. |
|
| placebo | Drug | 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion. |
|
| NIH stroke scale(NIHSS) |
The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1 |
| Day 0, Day7, Day 14, Day 30, Day 60, Day 90 |
| EQ-5D scale | Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 |
| Global disability on mRS at Day 90. | The proportion of patients with mRS ≥3 at Day 90. | Day 90 |
| Incidence of new-onset major vascular events in 90 days | Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death. | Day 90 |
| Overall mortality at day 90 | Day 90 |
| Incidence of severe hemorrhages in 90 days | The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment. | Day 90 |
| Incidence of moderate hemorrhages in 90 days | The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise. | Day 90 |
| Documentation of adverse events (AEs) and serious AEs | 90 days |
| Xinqiao Hospital of Third Military Medical University |
| Chongqing |
| Chongqing Municipality |
| 400037 |
| China |
| Chongqing Three Gorges Central Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| Guangdong No.2 Provincial People's Hospital | Guangzhou | Guangdong | 510317 | China |
| Guangzhou hospital of integrated Chinese and Western medicine | Guangzhou | Guangdong | 510813 | China |
| The Second People's Hospital of Shenzhen | Shenzhen | Guangdong | 518028 | China |
| The Second Central Hospital of Baoding City | Baoding | Hebei | 072750 | China |
| Affiliated Hospital of Chengde Medical University | Chengde | Hebei | 067000 | China |
| Handan Central Hospital | Handan | Hebei | 056001 | China |
| The Second Affiliated Hopital of Harbin Medical University | Harbin | Helongjiang | 150001 | China |
| The Second Chinese Medical Hospital of Luoyang City | Luoyang | Henan | 471003 | China |
| Nanyang T.C.M. Hospital | Nanyang | Henan | 473007 | China |
| Nanshi Hospital of Nanyang | Nanyang | Henan | 473065 | China |
| The First Affiliated Hospital of Henan University of T.C.M. | Zhengzhou | Henan | 450000 | China |
| People's Hospital of Zhengzhou | Zhengzhou | Henan | 450003 | China |
| Zhengzhou NO.7 People's Hospital | Zhengzhou | Henan | 450006 | China |
| Zhoukou Hospital of T.C.M. | Zhoukou | Henan | 466099 | China |
| The Central Hospital of Wuhan | Wuhan | Hubei | 430014 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430030 | China |
| Zhongshan Hospital of Hubei Province | Wuhan | Hubei | 430033 | China |
| Fifth Hospital in Wuhan | Wuhan | Hubei | 430050 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Tianyou Hospital Affiliated to Wuhan University of Science & Technology | Wuhan | Hubei | 430064 | China |
| Huangpi District Hospital of T.C.M. | Wuhan | Hubei | 430399 | China |
| Changsha Central Hospital | Changsha | Hunan | 410004 | China |
| The First Hospital of Changsha | Changsha | Hunan | 410005 | China |
| The second people's hospital of Hunan Province | Changsha | Hunan | 410007 | China |
| Xiangya Hospital Central-south University | Changsha | Hunan | 410008 | China |
| Nanjing Hospital of T.C.M. | Nanjing | Jiangsu | 210001 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210003 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| The Affiliated Hopital to Changchun University of Chinese Medicine | Changchun | Jilin | 130021 | China |
| The First Hospital Affiliated to Jilin University | Changchun | Jilin | 130021 | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130033 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130041 | China |
| Liaoyuan Traditional Chinese Medical Hospital | Liaoyuan | Jilin | 136299 | China |
| Anshan Central Hospital | Anshan | Liaoning | 114001 | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | 116001 | China |
| Dandong First Hospital | Dandong | Liaoning | 118015 | China |
| Panjin Central Hospital | Panjin | Liaoning | 124013 | China |
| People's Liberation Army No.202 Hospital | Shenyang | Liaoning | 110003 | China |
| The General Hospital of Shenyang Military | Shenyang | Liaoning | 110016 | China |
| People's Liberation Army No.463 Hospital | Shenyang | Liaoning | 110046 | China |
| Affiliated Hospital of Chifeng University | Chifeng | Neimenggu | 024005 | China |
| Fenyang Hospital of Shanxi Province | Lüliang | Shanxi | 032299 | China |
| The Second Affiliated Hospital to Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Affiliated Hospital of Shanxi University of Chinese Medicine | Xianyang | Shanxi | 712000 | China |
| The Second Affiliated Hospital of Shanxi University of T.C.M. | Xianyang | Shanxi | 712000 | China |
| Shanxi Province Hospital of T.C.M. | Xi’an | Shanxi | 710003 | China |
| The PLA Fourth Fifty-one Hospital | Xi’an | Shanxi | 710054 | China |
| Shanxi Provincial People's Hospital | Xi’an | Shanxi | 710068 | China |
| Teaching Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610072 | China |
| The First Affiliated Hopital of Chengdu Medical College | Chengdu | Sichuan | 610500 | China |
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality | 300193 | China |
| Xin Hua Hospital of Zhejiang Province | Hangzhou | Zhejiang | 310005 | China |
| Zhejiang Provincial Hospital of T.C.M. | Hangzhou | Zhejiang | 310006 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| Huzhou Central Hospital | Huzhou | Zhejiang | 313003 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Tiantan Hospital Affiliated to Capital Medical University | Beijing | 100050 | China |
| Xuan Wu Hospital Affiliated to Capital Medical University | Beijing | 100053 | China |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C540581 | danhong |
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