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Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity

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ClinicalTrials.gov Identifier: NCT02386852
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Luca Aquili, Sunway University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Cognition Drug: Placebo Drug: Ginseng Drug: Ginkgo Biloba Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo
Study subjects received, in a double blind fashion, placebo pills identical to the drug (ginseng: group 1; ginkgo biloba: group 2).
 Drug: Placebo
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)

Drug: Ginseng
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.

Drug: Ginkgo Biloba
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.
Experimental: Ginseng
Participants in the ginseng group received a medium, and higher dose of ginseng in addition to placebo capsules.
 Drug: Placebo
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)

Drug: Ginseng
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.
Experimental: Ginkgo Biloba
Participants in the ginkgo biloba group received a medium, and higher dose of ginkgo in addition to placebo capsules.
 Drug: Placebo
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)

Drug: Ginkgo Biloba
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake [ Time Frame: Acute effects (3 days of testing) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers ranging in age between 18 and 30.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386852


Locations
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Malaysia
Department of Psychology, Sunway University
Bandar Sunway, Selangor, Malaysia, 47500
Sponsors and Collaborators
Sunway University
Investigators
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Principal Investigator: Luca Aquili, PhD Sunway University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Luca Aquili, Sunway University
ClinicalTrials.gov Identifier: NCT02386852    
Other Study ID Numbers: Sunway-979
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015
Keywords provided by Dr. Luca Aquili, Sunway University:
Ginseng
Ginkgo Biloba
cardiovascular reactivity
cognition