Ginsenoside-Rd for Acute Ischemic Stroke
キーワード
概要
説明
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.
日付
| 最終確認済み: | 11/30/2007 |
| 最初に提出された: | 12/26/2007 |
| 提出された推定登録数: | 01/09/2008 |
| 最初の投稿: | 01/10/2008 |
| 最終更新が送信されました: | 08/29/2010 |
| 最終更新日: | 08/31/2010 |
| 実際の研究開始日: | 08/31/2005 |
| 一次完了予定日: | 05/31/2006 |
| 研究完了予定日: | 08/31/2006 |
状態または病気
介入/治療
Drug: ginsenoside-Rd 10mg
Drug: placebo
Drug: ginsenoside-Rd 20mg
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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 |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. NIHSS scores [15±1 days]
二次的な結果の測定
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]
