The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      While the use of herbals is increasing considerably, their efficacy and safety in the humans
      remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary
      data demonstrates that KRG can affect vascular function and our research group has previously
      shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive
      individuals. However, it is unknown which dose is the most effective in producing a desired
      effect. To address this issue, we will test escalating doses of a single Korean red ginseng
      batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most
      efficacious dose. The most promising dose will be extracted and will advance to next level to
      be tested again on BP control. The findings of the study may result in better ginseng
      standardization.
    

Detailed description: 
      Individuals will arrive at the Risk Factor Modification Centre, St. Michael's Hospital
      between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings.
      They will not have consumed any antihypertensive medications on the study mornings. Each
      visit will be separated by a minimum of a week. Since the half-life of ginsenosides in humans
      is less than 24-hours, to allow for a washout of approximately seven half-lives.

      In each of the four studies, when individuals arrive at our clinic on a test day they will
      first have their weight measured and subsequently rest in the seated position. They will then
      have a catheter inserted into a forearm vein, which will be kept patent by saline. From this
      device, a registered intravenous nurse will obtain a series of 7ml blood samples. Blood will
      be taken at 30-min intervals. Subsequently, individuals will fill out forms detailing their
      pharmacological regimen for the previous 24-hours and their diet (dinner) and activity
      (sleep, urination, morning routine) regimen for the previous 12-hours. As well, they will
      detail any adverse events that they experienced since their previous visit. Individuals will
      then have their office BP measured with a mercury sphygmomanometer until three consecutive
      measurements of both SBP and DBP <5 mmHg different are obtained. At this point, BP should be
      steady and subjects will be fitted with an ABPM. Measurements will be taken every 5-min for
      30-min, for a total of seven measurements. After the seventh measurement (time 0-min),
      measurements will be taken automatically every 10-min for 180-min. At time 0-min, treatment
      or placebo capsules will be consumed. At time 60-min a 360-calorie Ensure® breakfast will be
      consumed within 5-min. Blood samples will be drawn at 30-min intervals, starting at time
      0-min. For 24-hours after the ingestion of treatment, a record of any side effects will be
      detailed by the participants and then provided to us.
    

Intervention name(s): Korean Red Ginseng; Corn Starch
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500mg Capsulated Ground Dried Korean Red Ginseng Root; 500mg Capsulated Corn Starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment