HypertensionPhase 2ESGCNCT00728221
Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
A Phase 2 study testing Korean Red Ginseng, Korean Red Ginseng (Panax ginseng) and Cornstarch in people with Hypertension and Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Endothelial Function
- What is being tested?
- Korean Red Ginseng, Korean Red Ginseng (Panax ginseng) and Cornstarch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: between 18 and 70 years of age
- Healthy individuals (absence of major illnesses)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 1N8
About this study
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.
- Conditions
- Hypertension, Blood Pressure, Endothelial Function
- Being tested
- Korean Red Ginseng, Korean Red Ginseng (Panax ginseng), Cornstarch
- Keywords
- Ginseng, Korean Red Ginseng, Ginsenoside, Flow Mediated Dilation, Endothelial Function, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
Also called Kyonggi-do Farm, C. A. Meyer
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)Dietary supplement
Also called Kyonggi-do Farm, C. A. Meyer
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
Dosage form: total ginsenoside fraction in capsules
CornstarchDietary supplement
Placebo
Korean Red Ginseng (Panax Ginseng)Dietary supplement
Also called Kyonggi-do Farm, C. A. Meyer
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo capsules (3g) Receives: Dietary Supplement: Cornstarch |
| 2 | Experimental | Whole Korean Red Ginseng root (3g) Receives: Dietary Supplement: Korean Red Ginseng |
| 3 | Experimental | Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root Receives: Dietary Supplement: Korean Red Ginseng (Panax ginseng) |
| 4 | Experimental | Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root Receives: Dietary Supplement: Korean Red Ginseng (Panax Ginseng) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the brachial artery
Measured: Start and finish of each treatment arm
Secondary outcomes (2)
Augmentation Index
Measured: Start and finish of each treatment arm
Nitric Oxide and Cyclic GMP
Measured: Beginning of and 3 hours into clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, St. Michael's Hospital, University of TorontoAlexandra Jenkins, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728221
- Sponsor's protocol ID
- 118328
- Acronym
- ESGC
- Status last verified
- Jan 2017
- First submitted
- 1 Aug 2008
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24758417Jovanovski 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.
PubMed 20134405
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
- ClinicalTrials.gov ID
- NCT00728221
- Acronym / sponsor ID
- ESGC / 118328
- Conditions
- Hypertension, Blood Pressure, Endothelial Function
- Keywords
- Ginseng, Korean Red Ginseng, Ginsenoside, Flow Mediated Dilation, Endothelial Function, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: CornstarchPlacebo capsules (3g) |
| 2 | Experimental | Dietary Supplement: Korean Red GinsengWhole Korean Red Ginseng root (3g) |
| 3 | Experimental | Dietary Supplement: Korean Red Ginseng (Panax ginseng)Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root |
| 4 | Experimental | Dietary Supplement: Korean Red Ginseng (Panax Ginseng)Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: between 18 and 70 years of age
- Healthy individuals (absence of major illnesses)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red GinsengAlso: Kyonggi-do Farm, C. A. MeyerCultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g) | Dietary supplement | 2 |
| Korean Red Ginseng (Panax ginseng)Also: Kyonggi-do Farm, C. A. MeyerCultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules | Dietary supplement | 3 |
| CornstarchPlacebo | Dietary supplement | 1 |
| Korean Red Ginseng (Panax Ginseng)Also: Kyonggi-do Farm, C. A. MeyerCultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total polysaccharide fraction (panaxans) in capsules | Dietary supplement | 4 |
Primary outcome
Flow-mediated dilation of the brachial artery
Time frame: Start and finish of each treatment arm
2 secondary outcomes
Augmentation Index
Time frame: Start and finish of each treatment arm
Nitric Oxide and Cyclic GMP
Time frame: Beginning of and 3 hours into clinical visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Background: PubMed 24758417Jovanovski 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.
- Results publication: PubMed 20134405Jovanovski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Vuksan, PhD principal investigator
St. Michael's Hospital, University of Toronto
Alexandra Jenkins, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Korean Red Ginseng, Korean Red Ginseng (Panax ginseng) and Cornstarch in people with Hypertension and Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation of the brachial artery (time frame: Start and finish of each treatment arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728221, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.