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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation

Resource links provided by NLM:


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
Placebo Comparator: 1
Placebo capsules (3g)
Dietary Supplement: Cornstarch
Placebo
Experimental: 2
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)

Other Names:
  • Kyonggi-do Farm
  • C. A. Meyer
Experimental: 3
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

Other Names:
  • Kyonggi-do Farm
  • C. A. Meyer
Experimental: 4
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

Other Names:
  • Kyonggi-do Farm
  • C. A. Meyer

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Dr. Vladimir Vuksan, PhD, St. Michael's Hospital Risk Factor Modification Centre
ClinicalTrials.gov Identifier: NCT00728221     History of Changes
Other Study ID Numbers: 118328
Study First Received: August 1, 2008
Last Updated: August 1, 2008
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014