Preventive Effects of Ginseng Against Atherosclerosis

Not Applicable

Completed

• Conditions: Ischemic Stroke; Atherosclerosis
• Interventions: Dietary Supplement: Ginseng; Dietary Supplement: Placebo

• Registration Number: NCT02796664
• Lead Sponsor: Dae Chul Suh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Study Start: 2016-06-23
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Results First Submitted: 2021-05-18
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Results First Posted: 2021-08-24
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginseng	Ginseng	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack	Twelve months after randomization.	The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Modified Rankin Scale	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 Outcome Measures

Name	Time	Method
Number of Participants With Changes of Parenchymal Ischemic Lesions	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.
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.	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.
The Changes of White Matter Hyperintensities.	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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of