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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Blood Pressure, Endothelial Function

Intervention / Treatment
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* Dietary Supplement: Korean Red Ginseng
* Dietary Supplement: Korean Red Ginseng (Panax ginseng)
* Dietary Supplement: Cornstarch
* Dietary Supplement: Korean Red Ginseng (Panax Ginseng)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo capsules (3g) | Dietary Supplement: Cornstarch<br>* Placebo<br>|
| Experimental: 2<br>Whole Korean Red Ginseng root (3g) | Dietary Supplement: Korean Red Ginseng<br>* Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)<br>* Other names: C. A. Meyer;|
| Experimental: 3<br>Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root | Dietary Supplement: Korean Red Ginseng (Panax ginseng)<br>* Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules<br>* Other names: C. A. Meyer;|
| Experimental: 4<br>Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root | Dietary Supplement: Korean Red Ginseng (Panax Ginseng)<br>* 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<br>* Other names: C. A. Meyer;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginseng, Korean Red Ginseng, Ginsenoside, Flow Mediated Dilation, Endothelial Function, Hypertension