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Completed

NCT Number: NCT02796664

Preventive Effects of Ginseng Against Atherosclerosis

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

"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.

Treatment and study plan

Ginseng

Dietary Supplement

Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.

Placebo

Dietary Supplement

Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.

Primary outcomes

  1. The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack

    Time frame: Twelve months after randomization.

    The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion

  2. Modified Rankin Scale

    Time frame: 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.

Secondary outcomes

  1. The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.

    Time frame: At randomization and twelve months after randomization.

    The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis.

  2. The Changes of White Matter Hyperintensities.

    Time frame: At randomization and twelve months after randomization.

    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.

  3. Number of Participants With Changes of Parenchymal Ischemic Lesions

    Time frame: At randomization and twelve months after randomization.

    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.

Other outcomes

  1. Drug Compliance

    Time frame: At twelve months after randomization.

    We calculated average drug compliance based on the number of remained drugs at each follow-up.

Sponsors and collaborators

Lead sponsor

Dae Chul Suh

Other

Collaborators

  • Korea Ginseng Corporation

Registry information

Official study title

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

Acronym: PEGASUS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2016
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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