Preventive Effects of Ginseng Against Atherosclerosis (PEGASUS)

August 2, 2021 updated by: Dae Chul Suh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

"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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
Experimental: Ginseng
Dietary supplement: Ginseng
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Twelve months after randomization.
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.
Twelve months after randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At randomization and twelve months after randomization.
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.
At randomization and twelve months after randomization.
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.
At randomization and twelve months after randomization.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At twelve months after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dae Chul Suh

Collaborators

Korea Ginseng Corporation

Investigators

  • Principal Investigator: Dae Chul Suh, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2016

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGC2016-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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