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

Hypertension Clinical Trial

— ESGC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728221
• Other study ID #: 118328
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2008
• Last updated: January 5, 2017
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2017
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure
• Endothelial Function
• Hypertension

Intervention

Dietary Supplement:
• Korean Red Ginseng
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)
• Korean Red Ginseng (Panax ginseng)
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules
• Cornstarch
Placebo
• Korean Red Ginseng (Panax Ginseng)
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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Jovanovski E, Jenkins A, Dias AG, Peeva V, Sievenpiper J, Arnason JT, Rahelic D, Josse RG, Vuksan V. Effects of Korean red ginseng (Panax ginseng C.A. Mayer) and its isolated ginsenosides and polysaccharides on arterial stiffness in healthy individuals. A — View Citation

Jovanovski E, Peeva V, Sievenpiper JL, Jenkins AL, Desouza L, Rahelic D, Sung MK, Vuksan V. Modulation of endothelial function by Korean red ginseng (Panax ginseng C.A. Meyer) and its components in healthy individuals: a randomized controlled trial. Cardiovasc Ther. 2014 Aug;32(4):163-9. doi: 10.1111/1755-5922.12077. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation of the brachial artery		Start and finish of each treatment arm	No
Secondary	Augmentation Index		Start and finish of each treatment arm	No
Secondary	Nitric Oxide and Cyclic GMP		Beginning of and 3 hours into clinical visit	Yes