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Clinical Trials/NCT02796664
NCT02796664CompletedNot Applicable

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

Dae Chul Suh2 sites in 1 country58 target enrollmentStarted: June 23, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
58
Locations
2
Primary Endpoint
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

  • Number of Participants With Changes of Parenchymal Ischemic Lesions(At randomization and twelve months after randomization.)
  • The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.(At randomization and twelve months after randomization.)
  • The Changes of White Matter Hyperintensities.(At randomization and twelve months after randomization.)

Investigators

Sponsor
Dae Chul Suh
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dae Chul Suh

Professor

Asan Medical Center

Study Sites (2)

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