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

Phase 2

Completed

• Conditions: Hypertension; Blood Pressure; Endothelial Function
• Interventions: Dietary Supplement: Cornstarch; Dietary Supplement: Korean Red Ginseng (Panax Ginseng); Dietary Supplement: Korean Red Ginseng

• Registration Number: NCT00728221
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Cornstarch	Placebo capsules (3g)
3	Korean Red Ginseng (Panax Ginseng)	Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root
4	Korean Red Ginseng (Panax Ginseng)	Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root
2	Korean Red Ginseng	Whole Korean Red Ginseng root (3g)

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation of the brachial artery	Start and finish of each treatment arm

Secondary Outcome Measures

Name	Time	Method
Nitric Oxide and Cyclic GMP	Beginning of and 3 hours into clinical visit
Augmentation Index	Start and finish of each treatment arm

Trial Locations

Locations (1)

St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre; 🇨🇦 Toronto, Ontario, Canada