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Ginsenoside-Rd for Acute Ischemic Stroke

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Xijing Hospital

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Abstrè

The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Deskripsyon

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.

Dat

Dènye verifye: 11/30/2007
Premye Soumèt: 12/26/2007
Enskripsyon Estimasyon Soumèt: 01/09/2008
Premye afiche: 01/10/2008
Dènye Mizajou Soumèt: 08/29/2010
Dènye Mizajou afiche: 08/31/2010
Dat aktyèl kòmanse etid la: 08/31/2005
Dat Estimasyon Prensipal Estimasyon an: 05/31/2006
Dat estime fini etid la: 08/31/2006

Kondisyon oswa maladi

Ischemic Stroke

Entèvansyon / tretman

Drug: ginsenoside-Rd 10mg

Drug: placebo

Drug: ginsenoside-Rd 20mg

Faz

Faz 2

Gwoup bra

BraEntèvansyon / tretman
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

Kritè kalifikasyon yo

Laj ki kalifye pou etid 18 Years Pou 18 Years
Sèks ki kalifye pou etidAll
Aksepte Volontè HealthyWi
Kritè

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

Rezilta

Mezi Rezilta Prensipal yo

1. NIHSS scores [15±1 days]

Mezi Rezilta Segondè

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]

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