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Completed

NCT Number: NCT01951443

Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure

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

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Key information

Conditions

Arterial Stiffness, Blood Pressure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginseng

Dietary Supplement

400mg of encapsulated Rg3-KRG

Wheat Bran

Dietary Supplement

400mg of encapsulated wheat bran

Primary outcomes

  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 outcomes

  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 outcomes

  1. To evaluate the acute safety of Rg3-KRG in healthy adult volunteers using a 48hr symptoms questionnaire.

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study 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

Acronym: KRAB

Important dates

Study start
2013
Primary completion
2014
First posted
Sep 26, 2013
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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