Arterial Stiffness, Blood PressurePhase 1KRABNCT01951443
Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure
A Phase 1 study testing Ginseng and Wheat Bran in people with Arterial Stiffness, Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Blood Pressure
- What is being tested?
- Ginseng and Wheat Bran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 1
- 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
- Healthy
- Age 18-70 years
- BMI < 30 kg/m2
- Brachial systolic blood pressure < 140 mmHg
- Brachial diastolic blood pressure < 90 mmHg
- Main Exclusion Criteria:
Show all 9Show fewer
- BMI >30kg/m2
- Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
- Pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals
The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure
- Conditions
- Arterial Stiffness, Blood Pressure
- Being tested
- Ginseng, Wheat Bran
- Keywords
- ginseng, clinical trial, vascular, ginsenosides, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GinsengDietary supplement
400mg of encapsulated Rg3-KRG
Wheat BranDietary supplement
400mg of encapsulated wheat bran
| Study group | Role | What they receive |
|---|---|---|
| Ginseng | Experimental | Encapsulated 400mg Rg3-KRG extract Receives: Dietary Supplement: Ginseng |
| Wheat Bran | Placebo comparator | 400mg Wheat Bran capsule Receives: Dietary Supplement: Wheat Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx).
Measured: Two weeks (measurements taken on two separate visits with minimum one week washout)
Secondary outcomes (1)
To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers.
Measured: Two weeks (measurements taken on two separate visits with minimum one week washout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Stiffness, Blood PressureStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Vladimir Vuksan, PhD, Principal investigator, Risk Factor Modification Centre - St. Michael's HospitalDr. Amir Hanna (Qualified investigator), MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951443
- Sponsor's protocol ID
- KRAB
- Acronym
- KRAB
- Status last verified
- Mar 2014
- First submitted
- 21 Aug 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01951443
- Acronym / sponsor ID
- KRAB / KRAB
- Conditions
- Arterial Stiffness, Blood Pressure
- Keywords
- ginseng, clinical trial, vascular, ginsenosides, blood pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 26 Sep 2013 (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.
The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginseng | Experimental | Dietary Supplement: GinsengEncapsulated 400mg Rg3-KRG extract |
| Wheat Bran | Placebo comparator | Dietary Supplement: Wheat Bran400mg Wheat Bran capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy
- Age 18-70 years
- BMI < 30 kg/m2
- Brachial systolic blood pressure < 140 mmHg
- Brachial diastolic blood pressure < 90 mmHg
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ginseng400mg of encapsulated Rg3-KRG | Dietary supplement | Ginseng |
| Wheat Bran400mg of encapsulated wheat bran | Dietary supplement | Wheat Bran |
Primary outcome
To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx).
Time frame: Two weeks (measurements taken on two separate visits with minimum one week washout)
1 secondary outcome
To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers.
Time frame: Two weeks (measurements taken on two separate visits with minimum one week washout)
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 28 Apr 2014.
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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.
Dr. Vladimir Vuksan, PhD principal investigator
Risk Factor Modification Centre - St. Michael's Hospital
Dr. Amir Hanna (Qualified investigator), MD 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 1 study testing Ginseng and Wheat Bran in people with Arterial Stiffness, 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 9 inclusion and 0 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 28 Apr 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx). (time frame: Two weeks (measurements taken on two separate visits with minimum one week washout)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2014.