Ginsenoside-Rd for Acute Ischemic Stroke
Клучни зборови
Апстракт
Опис
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.
Датуми
Последен пат проверено: | 11/30/2007 |
Прво доставено: | 12/26/2007 |
Поднесено е проценето запишување: | 01/09/2008 |
Прво објавено: | 01/10/2008 |
Последното ажурирање е доставено: | 08/29/2010 |
Последно ажурирање објавено: | 08/31/2010 |
Крај на датумот на започнување на студијата: | 08/31/2005 |
Проценет датум на примарно завршување: | 05/31/2006 |
Проценет датум на завршување на студијата: | 08/31/2006 |
Состојба или болест
Интервенција / третман
Drug: ginsenoside-Rd 10mg
Drug: placebo
Drug: ginsenoside-Rd 20mg
Фаза
Групи за раце
Рака | Интервенција / третман |
---|---|
Experimental: ginsenoside-Rd 10mg 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. | Drug: ginsenoside-Rd 10mg infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days |
Placebo Comparator: placebo 2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed. | Drug: placebo infusion placebo (group B)once a day and continued for 14 days |
Experimental: ginsenoside-Rd 20mg 2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed | Drug: ginsenoside-Rd 20mg infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days |
Критериуми за подобност
Возраст подобни за студии | 18 Years До 18 Years |
Полови квалификувани за студии | All |
Прифаќа здрави волонтери | Да |
Критериуми | Inclusion Criteria: - between 18 to 75 years - the first episode - from onset to admission within 72 hours - NIHSS scores:5~22 Exclusion Criteria: - had other intracranial pathologies (e.g., tumor, infection) - had a neurologic or psychiatric disease - had a coexisting condition that limited their life expectancy - had significant drug or alcohol misuse - had high-grade carotid artery stenosis for which surgery was planned - were pregnant or nursing - participated in a clinical trial with an investigational drug or device within the past 3 months - were unlikely to be available for follow-up |
Исход
Мерки на примарниот исход
1. NIHSS scores [15±1 days]
Секундарни мерки на исходот
1. NIHSS scores [8 days]
2. the Barthel index [8 days]
3. the Barthel index [15 days]
4. the modified Rankin scale [15 days]
5. the modified Rankin scale [90 days]