NCT02386852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 6, 2015

Last Update Submit

March 11, 2015

Conditions

Blood PressureCognition

Keywords

GinsengGinkgo Bilobacardiovascular reactivitycognition

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance as modulated by either ginseng or ginkgo biloba

    Cognitive effects on tests of vigilance/attention, behavioural flexibility and executive functioning

    Acute effects (3 days of testing)

Secondary Outcomes (1)

  • Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake

    Acute effects (3 days of testing)

Study Arms (3)

Placebo

EXPERIMENTAL

Study subjects received, in a double blind fashion, placebo pills identical to the drug (ginseng: group 1; ginkgo biloba: group 2).

Drug: PlaceboDrug: GinsengDrug: Ginkgo Biloba

Ginseng

EXPERIMENTAL

Participants in the ginseng group received a medium, and higher dose of ginseng in addition to placebo capsules.

Drug: PlaceboDrug: Ginseng

Ginkgo Biloba

EXPERIMENTAL

Participants in the ginkgo biloba group received a medium, and higher dose of ginkgo in addition to placebo capsules.

Drug: PlaceboDrug: Ginkgo Biloba

Interventions

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)

Ginkgo BilobaGinsengPlacebo
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.

GinsengPlacebo
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.

Ginkgo BilobaPlacebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers ranging in age between 18 and 30.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Sunway University

Sunway City, Selangor, 47500, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 26938637DERIVED

MeSH Terms

Interventions

Asian ginsengGinkgo Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Luca Aquili, PhD

    Sunway University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Luca Aquili

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 12, 2015

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

MY(1)