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

Unity Health Toronto

Status and phase: Completed; Phase 2

Conditions: Endothelial Function; Hypertension; Blood Pressure

Treatments: Dietary Supplement: Korean Red Ginseng (Panax ginseng); Dietary Supplement: Korean Red Ginseng (Panax Ginseng); Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Cornstarch

Study type: Interventional

Funder types: Other

Identifiers

NCT00728221

118328

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo capsules (3g)

Treatment:

Dietary Supplement: Cornstarch

2

Experimental group

Description:

Whole Korean Red Ginseng root (3g)

Treatment:

Dietary Supplement: Korean Red Ginseng

3

Experimental group

Description:

Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root

Treatment:

Dietary Supplement: Korean Red Ginseng (Panax ginseng)

4

Experimental group

Description:

Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root

Treatment:

Dietary Supplement: Korean Red Ginseng (Panax Ginseng)