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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951443
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Arterial Stiffness, Blood Pressure Dietary Supplement: Ginseng Dietary Supplement: Wheat Bran Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951443


Locations
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Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Dr. Vladimir Vuksan, PhD Risk Factor Modification Centre - St. Michael's Hospital
Principal Investigator: Dr. Amir Hanna (Qualified investigator), MD St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01951443    
Other Study ID Numbers: KRAB
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: March 2014
Keywords provided by St. Michael's Hospital, Toronto:
ginseng
clinical trial
vascular
ginsenosides
blood pressure