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The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ginsenoside-Rd 10mg | Experimental | both a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed. |
|
| placebo | Placebo Comparator | 2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed. |
|
| ginsenoside-Rd 20mg | Experimental | 2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ginsenoside-Rd 10 mg | Drug | infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS scores | 15±1 days |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS scores | 8 days | |
| the Barthel index | 8 days | |
| the Barthel index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD | the Department of Neurology , Xijing Hospital; | Study Director |
| Xuedong Liu, MD | the Department of Neurology, Xijing Hospital; | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Department of Neurology , Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19236467 | Derived | Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19. |
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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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| ID | Term |
|---|---|
| C049863 | ginsenoside Rd |
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| placebo | Drug | infusion placebo (group B)once a day and continued for 14 days |
|
| ginsenoside-Rd 20mg | Drug | infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days |
|
| 15 days |
| the modified Rankin scale | 15 days |
| the modified Rankin scale | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |