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Preventive Effects of Ginseng Against Atherosclerosis

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ClinicalTrials.gov Identifier: NCT02796664
Recruitment Status : Unknown
Verified July 2016 by Dae Chul Suh, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
Korea Ginseng Corporation
Information provided by (Responsible Party):
Dae Chul Suh, Asan Medical Center

Brief Summary:
The purpose of this study is to determine whether Ginseng is effective in the prevention of atherosclerosis and subsequent ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Dietary Supplement: Ginseng Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preventive Effects of Ginseng Against Atherosclerosis and Subsequent Ischemic Stroke: A Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Ginseng

Arm Intervention/treatment
Active Comparator: Ginseng
2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months
Dietary Supplement: Ginseng
2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months

Placebo Comparator: Placebo
Placebo has the same appearance (same size and color) of the real drug. 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months
Dietary Supplement: Placebo
2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months




Primary Outcome Measures :
  1. Presence of ischemic stroke or TIA (transient ischemic attacks) assessed by symptom history during one year follow-up and measured by number of patients in each group [ Time Frame: one year ]
  2. Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (Modified Rankin Scale) at out-patient clinic during one year follow-up and measured by number of patients. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Changes in blood flow volume (ml/sec) in quantitative MRA measured by percentage change from the baseline study [ Time Frame: one year ]
  2. Changes in velocity (cm/sec) in quantitative MRA measured by percentage change from the baseline study [ Time Frame: one year ]
  3. New FLAIR MR lesion assessed on one year follow-up MRI and measured by number of patients. [ Time Frame: one year ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe stenosis or occlusion of the internal carotid artery, middle cerebral artery and vertebrobasilar system
  2. No adverse reaction to ginseng
  3. Aged between 20 to 80 years

Exclusion Criteria:

  1. Genetic cerebrovascular diseases
  2. Adverse reaction to contrast medium
  3. Pregnant woman
  4. History of previous cerebral angioplasty and stenting, carotid endarterectomy, and bypass surgery
  5. History of cardioembolic stroke or possibility of cardioembolic stroke
  6. Possibility of cancer stroke
  7. Renal failure (GFR< 30 ml/min) or liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796664


Contacts
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Contact: Sang Hun Lee 82-2-3010-1770 huny0029@naver.com
Contact: Dae Chul Suh 82-2-3010-4366 dcsuh@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Dae Chul Suh    82-2-3010-4366    dcsuh@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Korea Ginseng Corporation
Investigators
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Principal Investigator: Dae Chul Suh Asan Medical Center

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Responsible Party: Dae Chul Suh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02796664     History of Changes
Other Study ID Numbers: PEGASUS
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016

Keywords provided by Dae Chul Suh, Asan Medical Center:
Ginseng
Stroke
Quantitative MR flow analysis

Additional relevant MeSH terms:
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Stroke
Atherosclerosis
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases