The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00730951
First received: August 6, 2008
Last updated: NA
Last verified: August 2007
History: No changes posted

August 6, 2008
August 6, 2008
June 2007
January 2008   (final data collection date for primary outcome measure)
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor [ Time Frame: every 5 min for first 30 min, then every 10 minutes for 180 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Blood samples will be drawn and tested for Nitric Oxide levels. [ Time Frame: every 30 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation
The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Dietary Supplement: Korean Red Ginseng
    500mg Capsulated Ground Dried Korean Red Ginseng Root
  • Dietary Supplement: Corn Starch
    500mg Capsulated Corn Starch
  • Experimental: 1
    0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules)
    Interventions:
    • Dietary Supplement: Korean Red Ginseng
    • Dietary Supplement: Corn Starch
  • Experimental: 2
    1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules)
    Interventions:
    • Dietary Supplement: Korean Red Ginseng
    • Dietary Supplement: Corn Starch
  • Experimental: 3
    3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules)
    Interventions:
    • Dietary Supplement: Korean Red Ginseng
    • Dietary Supplement: Corn Starch
  • Experimental: 4
    6g Korean Red Ginseng (12 capsules)
    Intervention: Dietary Supplement: Korean Red Ginseng
  • Experimental: 5
    6g Corn Starch Control (12 capsules)
    Intervention: Dietary Supplement: Corn Starch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Essential Hypertension

Exclusion Criteria:

  • Secondary Hypertension
  • Diabetes
  • Chronic Kidney Disease
  • Liver Disease
  • Unstable Angina
  • Coronary / Cerebrovascular event in the previous 6 months
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00730951
107460
No
Dr. Vladimir Vuksan, Clinical Nutrition and Risk Factor Modification Centre
St. Michael's Hospital, Toronto
Heart and Stroke Foundation of Ontario
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutritian and Risk Factor Modification Centre
St. Michael's Hospital, Toronto
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP