Ginsenoside-Rd for Acute Ischemic Stroke
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 11/30/2007 |
| První předloženo: | 12/26/2007 |
| Odhadovaná registrace vložena: | 01/09/2008 |
| První zveřejnění: | 01/10/2008 |
| Poslední aktualizace byla odeslána: | 08/29/2010 |
| Poslední aktualizace zveřejněna: | 08/31/2010 |
| Aktuální datum zahájení studie: | 08/31/2005 |
| Odhadované datum dokončení primární: | 05/31/2006 |
| Odhadované datum dokončení studie: | 08/31/2006 |
Stav nebo nemoc
Intervence / léčba
Drug: ginsenoside-Rd 10mg
Drug: placebo
Drug: ginsenoside-Rd 20mg
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| 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 |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. NIHSS scores [15±1 days]
Měření sekundárních výsledků
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]
