Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation (ESGC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Blood Pressure Endothelial Function |
Dietary Supplement: Korean Red Ginseng Dietary Supplement: Korean Red Ginseng (Panax ginseng) Dietary Supplement: Cornstarch Dietary Supplement: Korean Red Ginseng (Panax Ginseng) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation |
- Flow-mediated dilation of the brachial artery [ Time Frame: Start and finish of each treatment arm ] [ Designated as safety issue: No ]
- Augmentation Index [ Time Frame: Start and finish of each treatment arm ] [ Designated as safety issue: No ]
- Nitric Oxide and Cyclic GMP [ Time Frame: Beginning of and 3 hours into clinical visit ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo capsules (3g)
|
Dietary Supplement: Cornstarch
Placebo
|
|
Experimental: 2
Whole Korean Red Ginseng root (3g)
|
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) Other Names:
|
|
Experimental: 3
Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root
|
Dietary Supplement: 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 Other Names:
|
|
Experimental: 4
Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root
|
Dietary Supplement: 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 Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Canada, Ontario | |
| St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre | |
| Toronto, Ontario, Canada, M5C 1N8 | |
| Principal Investigator: | Vladimir Vuksan, PhD | St. Michael's Hospital, University of Toronto |
| Principal Investigator: | Alexandra Jenkins, PhD | St. Michael's Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | Dr. Vladimir Vuksan, PhD, St. Michael's Hospital Risk Factor Modification Centre |
| ClinicalTrials.gov Identifier: | NCT00728221 History of Changes |
| Other Study ID Numbers: | 118328 |
| Study First Received: | August 1, 2008 |
| Last Updated: | August 1, 2008 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by St. Michael's Hospital, Toronto:
|
Ginseng Korean Red Ginseng Ginsenoside |
Flow Mediated Dilation Endothelial Function Hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013