Preventive Effects of Ginseng Against Atherosclerosis
キーワード
概要
日付
| 最終確認済み: | 06/30/2016 |
| 最初に提出された: | 05/25/2016 |
| 提出された推定登録数: | 06/06/2016 |
| 最初の投稿: | 06/12/2016 |
| 最終更新が送信されました: | 07/05/2016 |
| 最終更新日: | 07/06/2016 |
| 実際の研究開始日: | 05/31/2016 |
| 一次完了予定日: | 04/30/2017 |
状態または病気
介入/治療
Dietary Supplement: Ginseng
Dietary Supplement: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Ginseng 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months | Dietary Supplement: Ginseng 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months |
| Placebo Comparator: Placebo Placebo has the same appearance (same size and color) of the real drug. 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months | Dietary Supplement: Placebo 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months |
適格基準
| 研究の対象となる年齢 | 20 Years に 20 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: 1. Severe stenosis or occlusion of the internal carotid artery, middle cerebral artery and vertebrobasilar system 2. No adverse reaction to ginseng 3. Aged between 20 to 80 years Exclusion Criteria: 1. Genetic cerebrovascular diseases 2. Adverse reaction to contrast medium 3. Pregnant woman 4. History of previous cerebral angioplasty and stenting, carotid endarterectomy, and bypass surgery 5. History of cardioembolic stroke or possibility of cardioembolic stroke 6. Possibility of cancer stroke 7. Renal failure (GFR< 30 ml/min) or liver disease |
結果
主な結果の測定
1. Presence of ischemic stroke or TIA (transient ischemic attacks) assessed by symptom history during one year follow-up and measured by number of patients in each group [one year]
2. Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (Modified Rankin Scale) at out-patient clinic during one year follow-up and measured by number of patients. [one year]
二次的な結果の測定
1. Changes in blood flow volume (ml/sec) in quantitative MRA measured by percentage change from the baseline study [one year]
2. Changes in velocity (cm/sec) in quantitative MRA measured by percentage change from the baseline study [one year]
3. New FLAIR MR lesion assessed on one year follow-up MRI and measured by number of patients. [one year]
