Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure (KRAB)

April 25, 2014 updated by: Unity Health Toronto

Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals

The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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, M5B 1W8
        • Risk Factor Modification Centre, St. Michael's Hospital

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Age 18-70 years
  • BMI < 30 kg/m2
  • Brachial systolic blood pressure < 140 mmHg
  • Brachial diastolic blood pressure < 90 mmHg

Main Exclusion Criteria:

  • BMI >30kg/m2
  • Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
  • Pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ginseng
Encapsulated 400mg Rg3-KRG extract
Dietary supplement: Ginseng
400mg of encapsulated Rg3-KRG
Placebo Comparator: Wheat Bran
400mg Wheat Bran capsule
Dietary supplement: Wheat Bran
400mg of encapsulated wheat bran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx).
Time Frame: Two weeks (measurements taken on two separate visits with minimum one week washout)
Two weeks (measurements taken on two separate visits with minimum one week washout)

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers.
Time Frame: Two weeks (measurements taken on two separate visits with minimum one week washout)
Two weeks (measurements taken on two separate visits with minimum one week washout)

Other Outcome Measures

Outcome Measure
Time Frame
To evaluate the acute safety of Rg3-KRG in healthy adult volunteers using a 48hr symptoms questionnaire.
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Dr. Vladimir Vuksan, PhD, Risk Factor Modification Centre - St. Michael's Hospital
  • Principal Investigator: Dr. Amir Hanna (Qualified investigator), MD, Unity Health Toronto

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

August 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KRAB

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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