Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation (ESGC)

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00728221
First received: August 1, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

August 1, 2008
August 1, 2008
November 2007
April 2008   (final data collection date for primary outcome measure)
Flow-mediated dilation of the brachial artery [ Time Frame: Start and finish of each treatment arm ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Augmentation Index [ Time Frame: Start and finish of each treatment arm ] [ Designated as safety issue: No ]
  • Nitric Oxide and Cyclic GMP [ Time Frame: Beginning of and 3 hours into clinical visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation

Ginseng has been used for many years in a wide array of anecdotal medicinal properties. Animal and limited clinical research points to the vascular effects of Korean Red Ginseng (KRG). The present project aims to assess the efficacy of KRG and contribution of its factionated components on various indices of vascular function in healthy individuals. Our primary objective is to compare the acute effects of KRG and placebo on endothelial function. Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1) consumption of KRG will cause an improvement in endothelial function in healthy individuals, as compared to placebo; (2) consumption of KRG will cause an improvement in arterial stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hypertension
  • Blood Pressure
  • Endothelial Function
  • Dietary Supplement: Korean Red Ginseng

    Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.

    Dosage form: whole root in capsules (3g)

    Other Names:
    • Kyonggi-do Farm
    • C. A. Meyer
  • Dietary Supplement: Korean Red Ginseng (Panax ginseng)

    Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.

    Dosage form: total ginsenoside fraction in capsules

    Other Names:
    • Kyonggi-do Farm
    • C. A. Meyer
  • Dietary Supplement: Cornstarch
    Placebo
  • Dietary Supplement: Korean Red Ginseng (Panax Ginseng)

    Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.

    Dosage form: total polysaccharide fraction (panaxans) in capsules

    Other Names:
    • Kyonggi-do Farm
    • C. A. Meyer
  • Placebo Comparator: 1
    Placebo capsules (3g)
    Intervention: Dietary Supplement: Cornstarch
  • Experimental: 2
    Whole Korean Red Ginseng root (3g)
    Intervention: Dietary Supplement: Korean Red Ginseng
  • Experimental: 3
    Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root
    Intervention: Dietary Supplement: Korean Red Ginseng (Panax ginseng)
  • Experimental: 4
    Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root
    Intervention: Dietary Supplement: Korean Red Ginseng (Panax Ginseng)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
Not Provided
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: between 18 and 70 years of age
  • Healthy individuals (absence of major illnesses)

Exclusion Criteria:

  • Primary hypertension (defined by the use of antihypertensive agents or a seated systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than 90mmHg)
  • Secondary hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg)
  • Grade 3 hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg)
  • Diabetes
  • Chronic kidney disease
  • Liver disease
  • Estrogen-sensitive cancer
  • Heavy alcohol use
  • Bleeding disorders
  • Planned surgery
  • Angina
  • CHF
  • Coronary revascularization
  • Peripheral vascular disease
  • Coronary/cerebrovascular event in the last 6 months
  • Prescriptions of MAO inhibitors, SSRIs, diuretics, sympathomimetics, herbal therapies, medication affecting nitric oxide synthesis, and/or anticoagulent medications within the last 6 months
  • Sensitivity to any of the ingredients in the treatments or placebo
  • Chronic use of or frequent prescriptions for NSAIDs
  • Women of childbearing potential must not be pregnant or breast-feeding
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00728221
118328
No
Dr. Vladimir Vuksan, PhD, St. Michael's Hospital Risk Factor Modification Centre
St. Michael's Hospital, Toronto
Heart and Stroke Foundation of Ontario
Principal Investigator: Vladimir Vuksan, PhD St. Michael's Hospital, University of Toronto
Principal Investigator: Alexandra Jenkins, PhD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
March 2008

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