Preventive Effects of Ginseng Against Atherosclerosis (PEGASUS)

Dae Chul Suh

Status: Completed

Conditions: Ischemic Stroke; Atherosclerosis

Treatments: Dietary Supplement: Ginseng; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02796664

KGC2016-26

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

58 participants in 2 patient groups, including a placebo group

Ginseng

Experimental group

Treatment:

Dietary Supplement: Ginseng

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo