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

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

Sponsors

Lead sponsor: St. Michael's Hospital, Toronto

Collaborator: Heart and Stroke Foundation of Canada

Source St. Michael's Hospital, 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.

Overall Status Completed
Start Date November 2007
Completion Date April 2008
Primary Completion Date April 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Flow-mediated dilation of the brachial artery Start and finish of each treatment arm
Secondary Outcome
Measure Time Frame
Augmentation Index Start and finish of each treatment arm
Nitric Oxide and Cyclic GMP Beginning of and 3 hours into clinical visit
Enrollment 17
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Korean Red Ginseng

Description: Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)

Arm group label: 2

Intervention type: Dietary Supplement

Intervention name: Korean Red Ginseng (Panax ginseng)

Description: Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules

Arm group label: 3

Intervention type: Dietary Supplement

Intervention name: Cornstarch

Description: Placebo

Arm group label: 1

Intervention type: Dietary Supplement

Intervention name: Korean Red Ginseng (Panax Ginseng)

Description: 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

Arm group label: 4

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Location
facility
St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre
Location Countries

Canada

Verification Date

January 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: 1

Arm group type: Placebo Comparator

Description: Placebo capsules (3g)

Arm group label: 2

Arm group type: Experimental

Description: Whole Korean Red Ginseng root (3g)

Arm group label: 3

Arm group type: Experimental

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

Arm group label: 4

Arm group type: Experimental

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

Acronym ESGC
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov