Preventive Effects of Ginseng Against Atherosclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Preventive Effects of Ginseng Against Atherosclerosis and Subsequent Ischemic Stroke: A Randomized Controlled Trial

Conditions
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Ischemic Stroke, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginseng<br> | Dietary Supplement: Ginseng<br>* Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack | The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion | Twelve months after randomization. | 
| Modified Rankin Scale | 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. | Twelve months after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels. | The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis. | At randomization and twelve months after randomization. | 
| The Changes of White Matter Hyperintensities. | The changes of white matter hyperintensities, assessed by the Fazekas scale using brain magnetic resonance imaging. The Fazekas scale is a 4 point white matter disease severity scale with values ranging from 0 to 3. It quantifies the amount of white matter T2 hyperintense lesions each in periventricular white matter and deep white matter. Higher scales mean a worse white matter status. In the region of the periventricular white matter, 0 means absence of the lesion; 1, caps or pencil-thin lining lesion; 2, smooth halo lesion; 3, irregular high intense signal extending into the deep shite matter. In the region of the deep white matter, 0 means absence of the lesion; 1, punctate foci lesions; 2, beginning confluence; 3, large confluent hyperintense areas. | At randomization and twelve months after randomization. | 
| Number of Participants With Changes of Parenchymal Ischemic Lesions | The changes of ischemic parenchymal lesions, assessed by brain magnetic resonance images acquired at randomization and twelve months after randomization. We counted the number of participants who had new ischemic parenchymal lesions at twelve months after randomization. | At randomization and twelve months after randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginseng, Stroke, Quantitative magnetic resonance flow analysis