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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386852
• Other study ID #: Sunway-979
• Status: Completed
• Phase: Phase 0
• First received: March 6, 2015
• Last updated: March 11, 2015
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Sunway University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure
• Cognition

Intervention

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)
• 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.
• 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.

Locations

Country	Name	City	State
Malaysia	Department of Psychology, Sunway University	Bandar Sunway	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Sunway University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	Acute effects (3 days of testing)	No