Clinical trial NCT00728221: Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
Official title: Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Blood Pressure
Endothelial Function
Keywords: Ginseng
Korean Red Ginseng
Ginsenoside
Flow Mediated Dilation
Endothelial Function
Hypertension
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2008-08-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery
timeFrame: Start and finish of each treatment arm
Secondary outcomes:
measure: Augmentation Index
timeFrame: Start and finish of each treatment arm
measure: Nitric Oxide and Cyclic GMP
timeFrame: Beginning of and 3 hours into clinical visit
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Alexandra Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jovanovski E, Peeva V, Sievenpiper JL, Jenkins AL, Desouza L, Rahelic D, Sung MK, Vuksan V. Modulation of endothelial function by Korean red ginseng (Panax ginseng C.A. Meyer) and its components in healthy individuals: a randomized controlled trial. Cardiovasc Ther. 2014 Aug;32(4):163-9. doi: 10.1111/1755-5922.12077.
citation: Jovanovski E, Jenkins A, Dias AG, Peeva V, Sievenpiper J, Arnason JT, Rahelic D, Josse RG, Vuksan V. Effects of Korean red ginseng (Panax ginseng C.A. Mayer) and its isolated ginsenosides and polysaccharides on arterial stiffness in healthy individuals. Am J Hypertens. 2010 May;23(5):469-72. doi: 10.1038/ajh.2010.5. Epub 2010 Feb 4.