Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation (ESGC)
January 5, 2017 updated by: Unity Health Toronto
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 1N8
- St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
Placebo capsules (3g)
|
Placebo
|
|
Experimental: 2
Whole Korean Red Ginseng root (3g)
|
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)
Other Names:
|
|
Experimental: 3
Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root
|
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules
Other Names:
|
|
Experimental: 4
Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Flow-mediated dilation of the brachial artery
Time Frame: Start and finish of each treatment arm
|
Start and finish of each treatment arm
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Augmentation Index
Time Frame: Start and finish of each treatment arm
|
Start and finish of each treatment arm
|
|
Nitric Oxide and Cyclic GMP
Time Frame: Beginning of and 3 hours into clinical visit
|
Beginning of and 3 hours into clinical visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vladimir Vuksan, PhD, St. Michael's Hospital, University of Toronto
- Principal Investigator: Alexandra Jenkins, PhD, Unity Health Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Am J Hypertens. 2010 May;23(5):469-72. doi: 10.1038/ajh.2010.5. Epub 2010 Feb 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
August 1, 2008
First Submitted That Met QC Criteria
August 1, 2008
First Posted (Estimate)
August 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
January 5, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118328
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.