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| Name | Class |
|---|---|
| China Food and Drug Administration | OTHER_GOV |
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The purpose of this study is to explore the pharmacological mechanism of Danhong injection 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. |
|
| healthy volunteer | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danhong injection | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| The changes of serum proteomics in 36 patients selected from certain center | We wish to identify protein biomarkers in the blood that changed with Danhong treatment | Day 0, Day 14, Day 90 |
| The microRNA profile in 10 healthy volunteer |
Inclusion Criteria:
Female or male inpatients
Female or male healthy volunteer
Exclusion Criteria:
Female or male inpatients
Healthy volunteer
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| Name | Affiliation | Role |
|---|---|---|
| Wang Zhong, Professor | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
| Zhao Xingquan, Professor | Beijing Tiantan Hospital | Principal Investigator |
| Wang Yongyan, Professor | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Chair |
| Jiang Zhilin, Professor | 202 Military Hospital of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanshi Hospital of Nanyang | Nanyang | Henan | 473065 | China | ||
| Panjin Central Hospital |
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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 |
|---|---|
| C540581 | danhong |
| C079426 | Honghua extract, Carthamus tinctorius |
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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 |
|
| Day0 |
| The mRNA profiles in 10 healthy volunteer | Day0 |
| The proteomics profiles of 10 healthy volunteer | Day 0 |
| Panjin |
| Liaoning |
| 124013 |
| China |
| 202 Military Hospital of China | Shenyang | Liaoning | China |
| Affiliated Hospital of Chifeng University | Chifeng | Neimenggu | 024005 | China |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |