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Preventive Effects of Ginseng Against Atherosclerosis (PEGASUS)

Primary Purpose

Ischemic Stroke, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ginseng
Placebo
Sponsored by
Dae Chul Suh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring Ginseng, Stroke, Quantitative magnetic resonance flow analysis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

"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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginseng

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Modified Rankin Scale
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 Outcome Measures

The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis.
The Changes of White Matter Hyperintensities.
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.
Number of Participants With Changes of Parenchymal Ischemic Lesions
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.

Full Information

First Posted
May 26, 2016
Last Updated
August 2, 2021
Sponsor
Dae Chul Suh
Collaborators
Korea Ginseng Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02796664
Brief Title
Preventive Effects of Ginseng Against Atherosclerosis
Acronym
PEGASUS
Official Title
Preventive Effects of Ginseng Against Atherosclerosis and Subsequent Ischemic Stroke: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2016 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dae Chul Suh
Collaborators
Korea Ginseng Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Atherosclerosis
Keywords
Ginseng, Stroke, Quantitative magnetic resonance flow analysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginseng
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginseng
Intervention Description
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
Primary Outcome Measure Information:
Title
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
Description
The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Time Frame
Twelve months after randomization.
Title
Modified Rankin Scale
Description
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.
Time Frame
Twelve months after randomization.
Secondary Outcome Measure Information:
Title
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
Description
The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis.
Time Frame
At randomization and twelve months after randomization.
Title
The Changes of White Matter Hyperintensities.
Description
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.
Time Frame
At randomization and twelve months after randomization.
Title
Number of Participants With Changes of Parenchymal Ischemic Lesions
Description
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.
Time Frame
At randomization and twelve months after randomization.
Other Pre-specified Outcome Measures:
Title
Drug Compliance
Description
We calculated average drug compliance based on the number of remained drugs at each follow-up.
Time Frame
At twelve months after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Chul Suh
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29854792
Citation
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Results Reference
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Zhou Y, Li HQ, Lu L, Fu DL, Liu AJ, Li JH, Zheng GQ. Ginsenoside Rg1 provides neuroprotection against blood brain barrier disruption and neurological injury in a rat model of cerebral ischemia/reperfusion through downregulation of aquaporin 4 expression. Phytomedicine. 2014 Jun 15;21(7):998-1003. doi: 10.1016/j.phymed.2013.12.005. Epub 2014 Jan 22.
Results Reference
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PubMed Identifier
26384017
Citation
Bao C, Wang Y, Min H, Zhang M, Du X, Han R, Liu X. Combination of ginsenoside Rg1 and bone marrow mesenchymal stem cell transplantation in the treatment of cerebral ischemia reperfusion injury in rats. Cell Physiol Biochem. 2015;37(3):901-10. doi: 10.1159/000430217. Epub 2015 Sep 18.
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PubMed Identifier
23811400
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Results Reference
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PubMed Identifier
26886418
Citation
Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17.
Results Reference
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PubMed Identifier
26045754
Citation
Yang Y, Li X, Zhang L, Liu L, Jing G, Cai H. Ginsenoside Rg1 suppressed inflammation and neuron apoptosis by activating PPARgamma/HO-1 in hippocampus in rat model of cerebral ischemia-reperfusion injury. Int J Clin Exp Pathol. 2015 Mar 1;8(3):2484-94. eCollection 2015.
Results Reference
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PubMed Identifier
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Citation
Liu XY, Zhou XY, Hou JC, Zhu H, Wang Z, Liu JX, Zheng YQ. Ginsenoside Rd promotes neurogenesis in rat brain after transient focal cerebral ischemia via activation of PI3K/Akt pathway. Acta Pharmacol Sin. 2015 Apr;36(4):421-8. doi: 10.1038/aps.2014.156. Epub 2015 Mar 16.
Results Reference
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Citation
Chen LM, Zhou XM, Cao YL, Hu WX. Neuroprotection of ginsenoside Re in cerebral ischemia-reperfusion injury in rats. J Asian Nat Prod Res. 2008 May-Jun;10(5-6):439-45. doi: 10.1080/10286020801892292.
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Results Reference
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Preventive Effects of Ginseng Against Atherosclerosis

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