Blood PressureNCT01913210
Effect of Ginseng on Blood Pressure
An observational study of Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
Trial summary
To determine the effect of ginseng on blood pressure control. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Ginseng
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jan 2016
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hypertensive Healthy
Who may be able to join
- clinical trials in humans
- randomized treatment allocation
- ≥ 1 month
- suitable control
- viable endpoint data
Who cannot join
- non-human studies
- non-randomized treatment allocation
- < 1 month
- lack of a suitable control
- no viable endpoint data
- trials where ginseng is part of a multi-herbal treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 2T2
About this study
Official title: Effect of Ginseng on Blood Pressure: A Systematic Review and Meta-Analysis of Controlled Trials
To determine the effect of ginseng on blood pressure control.
Read the detailed description
The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control.
This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.
- Conditions
- Blood Pressure
- Being tested
- Ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GinsengDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: 1 month
Secondary outcomes (2)
Diastolic Blood Pressure
Measured: 1 month
Mean Arterial Pressure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health TorontoJohn Sievenpiper, MD, PhD, Principal investigator, Unity Health TorontoAllison Komishon, MSc(c), Study director, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913210
- Sponsor's protocol ID
- MetaBPG
- Status last verified
- Mar 2016
- First submitted
- 29 Jul 2013
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ginseng on Blood Pressure: A Systematic Review and Meta-Analysis of Controlled Trials
- ClinicalTrials.gov ID
- NCT01913210
- Acronym / sponsor ID
- MetaBPG
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Jul 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.
To determine the effect of ginseng on blood pressure control.
Detailed description
The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control.
This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypertensive Healthy
Key inclusion criteria (5 listed)
- clinical trials in humans
- randomized treatment allocation
- ≥ 1 month
- suitable control
- viable endpoint data
Key exclusion criteria (6 listed)
- non-human studies
- non-randomized treatment allocation
- < 1 month
- lack of a suitable control
- no viable endpoint data
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 |
|---|---|---|
| Ginseng | Dietary supplement | – |
Primary outcome
Systolic Blood Pressure
Time frame: 1 month
2 secondary outcomes
Diastolic Blood Pressure
Time frame: 1 month
Mean Arterial Pressure
Time frame: 1 month
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 3 Mar 2016.
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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
Unity Health Toronto
John Sievenpiper, MD, PhD principal investigator
Unity Health Toronto
Allison Komishon, MSc(c) study director
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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 3 Mar 2016. 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.
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?
Systolic Blood Pressure (time frame: 1 month). 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 3 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.