Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation - Full Text View

Sponsors and Collaborators:	St. Michael's Hospital, Toronto Heart and Stroke Foundation of Ontario
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00728221

Purpose

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.

Condition	Intervention	Phase
Hypertension Blood Pressure Endothelial Function	Dietary Supplement: Korean Red Ginseng Dietary Supplement: Korean Red Ginseng (Panax ginseng) Dietary Supplement: Cornstarch Dietary Supplement: Korean Red Ginseng (Panax Ginseng)	Phase II

MedlinePlus related topics: Dietary Supplements High Blood Pressure

Drug Information available for: Starch Ginseng

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Flow-mediated dilation of the brachial artery [ Time Frame: Start and finish of each treatment arm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	17
Study Start Date:	November 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo capsules (3g)	Dietary Supplement: Cornstarch Placebo
2: Experimental Whole Korean Red Ginseng root (3g)	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)
3: Experimental Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root	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
4: Experimental Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root	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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728221

Locations

Canada, Ontario
St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada, M5C 1N8

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:	Vladimir Vuksan, PhD	St. Michael's Hospital, University of Toronto
Principal Investigator:	Alexandra Jenkins, PhD	St. Michael's Hospital, Toronto

More Information

Responsible Party:	St. Michael's Hospital Risk Factor Modification Centre ( Dr. Vladimir Vuksan, PhD )
Study ID Numbers:	118328
Study First Received:	August 1, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00728221
Health Authority:	Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:

Ginseng
Korean Red Ginseng
Ginsenoside

Flow Mediated Dilation
Endothelial Function
Hypertension

Study placed in the following topic categories:

Dilatation, Pathologic
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009