Clinical trial NCT02796664: Preventive Effects of Ginseng Against Atherosclerosis
Official title: Preventive Effects of Ginseng Against Atherosclerosis and Subsequent Ischemic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Atherosclerosis
Keywords: Ginseng
Stroke
Quantitative magnetic resonance flow analysis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Ginseng Corporation
First posted: 2016-06-13
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: "Inclusion Criteria"

Patients were included if they

1. were aged 20 to 80 years;
2. 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;
3. had any risk factor for stroke, such as hypertension, diabetes mellitus, hypercholesterolemia, smoking, alcohol drinking, or previous stroke history;
4. had no adverse reactions to administration of ginseng; and
5. agreed to participate in the trial.

"Exclusion Criteria"

Patients were excluded if they

1. did not agree to participate in the trial;
2. had any genetic cerebrovascular diseases;
3. had adverse reactions to contrast medium;
4. were pregnant or planning to be pregnant;
5. had a history of cardioembolic stroke;
6. had an emboligenic cardiac disease such as atrial fibrillation, valve disease, congestive heart failure, or recent myocardial infarction;
7. had a risk of stroke of other determined etiology according to the TOAST classification;
8. had undergone any neurointervention procedure or surgery, such as intra-arterial thrombolysis, angioplasty procedures, carotid endarterectomy, or bypass surgery;
9. had chronic kidney disease (GFR \< 30 ml/min); or
10. had severe hepatic dysfunction.

Primary outcomes:
measure: The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
timeFrame: Twelve months after randomization.
measure: Modified Rankin Scale
timeFrame: Twelve months after randomization.
Secondary outcomes:
measure: The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
timeFrame: At randomization and twelve months after randomization.
measure: The Changes of White Matter Hyperintensities.
timeFrame: At randomization and twelve months after randomization.
measure: Number of Participants With Changes of Parenchymal Ischemic Lesions
timeFrame: At randomization and twelve months after randomization.
Other outcomes:
measure: Drug Compliance
timeFrame: At twelve months after randomization.
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Dae Chul Suh
role: PRINCIPAL_INVESTIGATOR
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