Preventive Effects of Ginseng Against Atherosclerosis and Subsequent Ischemic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
研究概览
简要总结
This study is a 12-month, double-blind, randomized, placebo-controlled trial. The purpose of this study is to determine whether ginseng is effective in the prevention of atherosclerosis and subsequent ischemic stroke. High-risk patients with severe atherosclerosis in the major intracranial arteries and extracranial carotid artery were enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"Inclusion Criteria"
- •Patients were included if they
- •were aged 20 to 80 years;
- •had occlusion or severe stenosis (≥ 70%) of extracranial carotid artery and major intracranial arteries (intracranial carotid artery, middle cerebral artery, anterior cerebral artery, intracranial vertebral, basilar, or posterior cerebral artery) as documented by cerebral catheter angiography;
- •had any risk factor for stroke, such as hypertension, diabetes mellitus, hypercholesterolemia, smoking, alcohol drinking, or previous stroke history;
- •had no adverse reactions to administration of ginseng; and
- •agreed to participate in the trial.
排除标准
- •Patients were excluded if they
- •did not agree to participate in the trial;
- •had any genetic cerebrovascular diseases;
- •had adverse reactions to contrast medium;
- •were pregnant or planning to be pregnant;
- •had a history of cardioembolic stroke;
- •had an emboligenic cardiac disease such as atrial fibrillation, valve disease, congestive heart failure, or recent myocardial infarction;
- •had a risk of stroke of other determined etiology according to the TOAST classification;
- •had undergone any neurointervention procedure or surgery, such as intra-arterial thrombolysis, angioplasty procedures, carotid endarterectomy, or bypass surgery;
- •had chronic kidney disease (GFR < 30 ml/min); or
- •had severe hepatic dysfunction.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Ginseng
干预措施: Ginseng (Dietary Supplement)
结局指标
主要结局
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
时间窗: Twelve months after randomization.
The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Modified Rankin Scale
时间窗: Twelve months after randomization.
Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (modified Rankin Scale). The modified Rankin Scale is ranging from 0 to 5. The higher scale indicates the worse outcome.
次要结局
- Number of Participants With Changes of Parenchymal Ischemic Lesions(At randomization and twelve months after randomization.)
- The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.(At randomization and twelve months after randomization.)
- The Changes of White Matter Hyperintensities.(At randomization and twelve months after randomization.)
研究者
Dae Chul Suh
Professor
Asan Medical Center