Preventive Effects of Ginseng Against Atherosclerosis

Recruiting

Phase 4 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: 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
  • Ginseng Dietary Supplement
    Intervention Desc: 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months
    ARM 1: Kind: Experimental
    Label: Ginseng
    Description: 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 one year Yes
Primary 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. one year Yes
Secondary Changes in blood flow volume (ml/sec) in quantitative MRA measured by percentage change from the baseline study one year Yes
Secondary Changes in velocity (cm/sec) in quantitative MRA measured by percentage change from the baseline study one year Yes
Secondary New FLAIR MR lesion assessed on one year follow-up MRI and measured by number of patients. one year Yes

Sponsors