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Completed

NCT Number: NCT00728221

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

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.

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Endothelial Function Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 1N8, Canada

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

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

Korean Red Ginseng (Panax ginseng)

Dietary Supplement

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

Cornstarch

Dietary Supplement

Placebo

Primary outcomes

  1. Flow-mediated dilation of the brachial artery

    Time frame: Start and finish of each treatment arm

Secondary outcomes

  1. Augmentation Index

    Time frame: Start and finish of each treatment arm

  2. Nitric Oxide and Cyclic GMP

    Time frame: Beginning of and 3 hours into clinical visit

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Acronym: ESGC

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 5, 2008
Registry last updated
Jan 6, 2017

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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