Blood PressureEarly Phase 1NCT02386852
Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
A Early Phase 1 study testing Ginseng and Ginkgo Biloba in people with Blood Pressure and Cognition, run by Sunway University at 1 site in Malaysia.
Trial summary
There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cognition
- What is being tested?
- Ginseng and Ginkgo Biloba
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2014to Nov 2014
- Phase
- Early 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers ranging in age between 18 and 30.
Who cannot join
- Ginseng group: exclude those that regularly consume caffeine or Panax Ginseng, or those that are diabetic, have hormone sensitive conditions, autoimmune diseases, bleeding conditions, heart conditions or take medications that are known to interact with Panax Ginseng. These include anticoagulants, Warfarin, Ibuprofen, MAOIs, medications that are changed by the liver, and stimulant drugs (e.g. pseudoephedrine, epinephrine).
- Ginkgo Biloba group: exclude those that regularly consume caffeine or Ginkgo Biloba, or those that are diabetic, have experienced seizures in the past, have bleeding disorders, or take medications that are known to interact with Ginkgo Biloba. These include Ibuprofen, anticoagulants, Warfarin, Buspirone, Fluoxetine, Trazodone
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Psychology, Sunway University
Sunway City, Selangor, 47500
About this study
There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.
- Conditions
- Blood Pressure, Cognition
- Being tested
- Placebo, Ginseng, Ginkgo Biloba
- Keywords
- Ginseng, Ginkgo Biloba, cardiovascular reactivity, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2)
GinsengDrug
The ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing.
Ginkgo BilobaDrug
The ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Study subjects received, in a double blind fashion, placebo pills identical to the drug (ginseng: group 1; ginkgo biloba: group 2). Receives: Drug: Placebo; Drug: Ginseng; Drug: Ginkgo Biloba |
| Ginseng | Experimental | Participants in the ginseng group received a medium, and higher dose of ginseng in addition to placebo capsules. Receives: Drug: Placebo; Drug: Ginseng |
| Ginkgo Biloba | Experimental | Participants in the ginkgo biloba group received a medium, and higher dose of ginkgo in addition to placebo capsules. Receives: Drug: Placebo; Drug: Ginkgo Biloba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance as modulated by either ginseng or ginkgo biloba
Cognitive effects on tests of vigilance/attention, behavioural flexibility and executive functioning
Measured: Acute effects (3 days of testing)
Secondary outcomes (1)
Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake
Changes in systolic, diastolic and heart rate reading as a result of ginseng or ginkgo biloba intake and dependent upon the type of cognitive domain assessed (i.e. vigilance, behavioural flexibility or executive functioning.
Measured: Acute effects (3 days of testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Luca Aquili, Sunway University
- Investigators
- Luca Aquili, PhD, Principal investigator, Sunway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386852
- Sponsor's protocol ID
- Sunway-979
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2015
- Last updated
- 13 Mar 2015
- Results posted
- No
Publications
Ong Lai Teik D, Lee XS, Lim CJ, Low CM, Muslima M, Aquili L. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial. PLoS One. 2016 Mar 3;11(3):e0150447. doi: 10.1371/journal.pone.0150447. eCollection 2016.
PubMed 26938637
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
- ClinicalTrials.gov ID
- NCT02386852
- Acronym / sponsor ID
- Sunway-979
- Conditions
- Blood Pressure, Cognition
- Keywords
- Ginseng, Ginkgo Biloba, cardiovascular reactivity, cognition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sunway UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Mar 2015 (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.
There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo, Drug: Ginseng, Drug: Ginkgo BilobaStudy subjects received, in a double blind fashion, placebo pills identical to the drug (ginseng: group 1; ginkgo biloba: group 2). |
| Ginseng | Experimental | Drug: Placebo, Drug: GinsengParticipants in the ginseng group received a medium, and higher dose of ginseng in addition to placebo capsules. |
| Ginkgo Biloba | Experimental | Drug: Placebo, Drug: Ginkgo BilobaParticipants in the ginkgo biloba group received a medium, and higher dose of ginkgo in addition to placebo capsules. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers ranging in age between 18 and 30.
Key exclusion criteria (2 listed)
- Ginseng group: exclude those that regularly consume caffeine or Panax Ginseng, or those that are diabetic, have hormone sensitive conditions, autoimmune diseases, bleeding conditions, heart conditions or take medications that are known to interact with Panax Ginseng. These include anticoagulants, Warfarin, Ibuprofen, MAOIs, medications that are changed by the liver, and stimulant drugs (e.g. pseudoephedrine, epinephrine).
- Ginkgo Biloba group: exclude those that regularly consume caffeine or Ginkgo Biloba, or those that are diabetic, have experienced seizures in the past, have bleeding disorders, or take medications that are known to interact with Ginkgo Biloba. These include Ibuprofen, anticoagulants, Warfarin, Buspirone, Fluoxetine, Trazodone
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 |
|---|---|---|
| PlaceboStudy subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2) | Drug | Ginkgo Biloba, Ginseng, Placebo |
| GinsengThe ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing. | Drug | Ginseng, Placebo |
| Ginkgo BilobaThe ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days. | Drug | Ginkgo Biloba, Placebo |
Primary outcome
Cognitive performance as modulated by either ginseng or ginkgo biloba
Time frame: Acute effects (3 days of testing)
Cognitive effects on tests of vigilance/attention, behavioural flexibility and executive functioning
1 secondary outcome
Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake
Time frame: Acute effects (3 days of testing)
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 13 Mar 2015.
- Derived from this study: PubMed 26938637Ong Lai Teik D, Lee XS, Lim CJ, Low CM, Muslima M, Aquili L. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial. PLoS One. 2016 Mar 3;11(3):e0150447. doi: 10.1371/journal.pone.0150447. eCollection 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.
Luca Aquili, PhD principal investigator
Sunway University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ginseng and Ginkgo Biloba in people with Blood Pressure and Cognition, run by Sunway University at 1 site in Malaysia.
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 2 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 13 Mar 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 Malaysia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Cognitive performance as modulated by either ginseng or ginkgo biloba (time frame: Acute effects (3 days of testing)). 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 NCT02386852, which also lists 1 linked publication.
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 13 Mar 2015.