N/A
Completed N=58
Preventive Effects of Ginseng Against Atherosclerosis
Source: ClinicalTrials.gov NCT02796664 ↗Enrolled (actual)
58
Serious AEs
1.7%
Results posted
Aug 2021
Primary outcomePrimary: The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack — 0; 0; 0; 1 Participants — p=0.462
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack |
0; 0; 0; 1 | 0.462 |
| PRIMARY Modified Rankin Scale |
21; 22; 5; 1; 0; 0 | 0.34 |
| SECONDARY The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels. |
4; 5; 17; 18; 7; 1 | 0.13 |
| SECONDARY The Changes of White Matter Hyperintensities. |
2; 1; 9; 11; 15; 10 | 0.74 |
| SECONDARY Number of Participants With Changes of Parenchymal Ischemic Lesions |
22; 15; 6; 9 | 0.23 |
Eligibility Criteria
"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.
Data sourced from ClinicalTrials.gov (NCT02796664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.