HypertensionPhase 2NCT00730951
The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation
A Phase 2 study testing Korean Red Ginseng and Corn Starch in people with Hypertension, run by Unity Health Toronto at 1 site in Canada.
Trial summary
While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Korean Red Ginseng and Corn Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential Hypertension
Who cannot join
- Secondary Hypertension
- Diabetes
- Chronic Kidney Disease
- Liver Disease
- Unstable Angina
- Coronary / Cerebrovascular event in the previous 6 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario
About this study
While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive individuals. However, it is unknown which dose is the most effective in producing a desired effect. To address this issue, we will test escalating doses of a single Korean red ginseng batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most efficacious dose. The most promising dose will be extracted and will advance to next level to be tested again on BP control. The findings of the study may result in better ginseng standardization.
Read the detailed description
Individuals will arrive at the Risk Factor Modification Centre, St. Michael's Hospital between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings. They will not have consumed any antihypertensive medications on the study mornings. Each visit will be separated by a minimum of a week. Since the half-life of ginsenosides in humans is less than 24-hours, to allow for a washout of approximately seven half-lives.
In each of the four studies, when individuals arrive at our clinic on a test day they will first have their weight measured and subsequently rest in the seated position. They will then have a catheter inserted into a forearm vein, which will be kept patent by saline. From this device, a registered intravenous nurse will obtain a series of 7ml blood samples. Blood will be taken at 30-min intervals. Subsequently, individuals will fill out forms detailing their pharmacological regimen for the previous 24-hours and their diet (dinner) and activity (sleep, urination, morning routine) regimen for the previous 12-hours. As well, they will detail any adverse events that they experienced since their previous visit. Individuals will then have their office BP measured with a mercury sphygmomanometer until three consecutive measurements of both SBP and DBP <5 mmHg different are obtained. At this point, BP should be steady and subjects will be fitted with an ABPM. Measurements will be taken every 5-min for 30-min, for a total of seven measurements. After the seventh measurement (time 0-min), measurements will be taken automatically every 10-min for 180-min. At time 0-min, treatment or placebo capsules will be consumed. At time 60-min a 360-calorie Ensure® breakfast will be consumed within 5-min. Blood samples will be drawn at 30-min intervals, starting at time 0-min. For 24-hours after the ingestion of treatment, a record of any side effects will be detailed by the participants and then provided to us.
- Conditions
- Hypertension
- Being tested
- Korean Red Ginseng, Corn Starch
- 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
500mg Capsulated Ground Dried Korean Red Ginseng Root
Corn StarchDietary supplement
500mg Capsulated Corn Starch
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules) Receives: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Corn Starch |
| 2 | Experimental | 1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules) Receives: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Corn Starch |
| 3 | Experimental | 3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules) Receives: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Corn Starch |
| 4 | Experimental | 6g Korean Red Ginseng (12 capsules) Receives: Dietary Supplement: Korean Red Ginseng |
| 5 | Experimental | 6g Corn Starch Control (12 capsules) Receives: Dietary Supplement: Corn Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor
Measured: every 5 min for first 30 min, then every 10 minutes for 180 minutes
Secondary outcomes (1)
Blood samples will be drawn and tested for Nitric Oxide levels.
Measured: every 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Clinical Nutritian and Risk Factor Modification Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730951
- Sponsor's protocol ID
- 107460
- Status last verified
- Jul 2015
- First submitted
- 6 Aug 2008
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation
- ClinicalTrials.gov ID
- NCT00730951
- Acronym / sponsor ID
- 107460
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 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.
While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive individuals. However, it is unknown which dose is the most effective in producing a desired effect. To address this issue, we will test escalating doses of a single Korean red ginseng batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most efficacious dose. The most promising dose will be extracted and will advance to next level to be tested again on BP control. The findings of the study may result in better ginseng standardization.
Detailed description
Individuals will arrive at the Risk Factor Modification Centre, St. Michael's Hospital between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings. They will not have consumed any antihypertensive medications on the study mornings. Each visit will be separated by a minimum of a week. Since the half-life of ginsenosides in humans is less than 24-hours, to allow for a washout of approximately seven half-lives.
In each of the four studies, when individuals arrive at our clinic on a test day they will first have their weight measured and subsequently rest in the seated position. They will then have a catheter inserted into a forearm vein, which will be kept patent by saline. From this device, a registered intravenous nurse will obtain a series of 7ml blood samples. Blood will be taken at 30-min intervals. Subsequently, individuals will fill out forms detailing their pharmacological regimen for the previous 24-hours and their diet (dinner) and activity (sleep, urination, morning routine) regimen for the previous 12-hours. As well, they will detail any adverse events that they experienced since their previous visit. Individuals will then have their office BP measured with a mercury sphygmomanometer until three consecutive measurements of both SBP and DBP <5 mmHg different are obtained. At this point, BP should be steady and subjects will be fitted with an ABPM. Measurements will be taken every 5-min for 30-min, for a total of seven measurements. After the seventh measurement (time 0-min), measurements will be taken automatically every 10-min for 180-min. At time 0-min, treatment or placebo capsules will be consumed. At time 60-min a 360-calorie Ensure® breakfast will be consumed within 5-min. Blood samples will be drawn at 30-min intervals, starting at time 0-min. For 24-hours after the ingestion of treatment, a record of any side effects will be detailed by the participants and then provided to us.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Korean Red Ginseng, Dietary Supplement: Corn Starch0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules) |
| 2 | Experimental | Dietary Supplement: Korean Red Ginseng, Dietary Supplement: Corn Starch1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules) |
| 3 | Experimental | Dietary Supplement: Korean Red Ginseng, Dietary Supplement: Corn Starch3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules) |
| 4 | Experimental | Dietary Supplement: Korean Red Ginseng6g Korean Red Ginseng (12 capsules) |
| 5 | Experimental | Dietary Supplement: Corn Starch6g Corn Starch Control (12 capsules) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential Hypertension
Key exclusion criteria (6 listed)
- Secondary Hypertension
- Diabetes
- Chronic Kidney Disease
- Liver Disease
- Unstable Angina
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 Ginseng500mg Capsulated Ground Dried Korean Red Ginseng Root | Dietary supplement | 1, 2, 3, 4 |
| Corn Starch500mg Capsulated Corn Starch | Dietary supplement | 1, 2, 3, 5 |
Primary outcome
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor
Time frame: every 5 min for first 30 min, then every 10 minutes for 180 minutes
1 secondary outcome
Blood samples will be drawn and tested for Nitric Oxide levels.
Time frame: every 30 minutes
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 31 Jul 2015.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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
Clinical Nutritian and Risk Factor Modification Centre
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 and Corn Starch in people with Hypertension, 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 1 inclusion and 6 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 31 Jul 2015. 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. 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?
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor (time frame: every 5 min for first 30 min, then every 10 minutes for 180 minutes). 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 31 Jul 2015.