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

January 5, 2017 updated by: Unity Health Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flow-mediated dilation of the brachial artery
Time Frame: Start and finish of each treatment arm
Start and finish of each treatment arm

Secondary Outcome Measures

Outcome Measure
Time Frame
Augmentation Index
Time Frame: Start and finish of each treatment arm
Start and finish of each treatment arm
Nitric Oxide and Cyclic GMP
Time Frame: Beginning of and 3 hours into clinical visit
Beginning of and 3 hours into clinical visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Heart and Stroke Foundation of Canada

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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