Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects

Brain Waves Clinical Trial

Official title:

Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects. A Prospective, Randomized, Double Blind, Placebo-controlled, 3-armed Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167449
• Other study ID #: EP-1006
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2021
• Source: EuroPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject must be capable of giving informed consent.
• Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).

Exclusion Criteria:

• Subjects with acute or chronic diseases that are relevant to the study and asked for

by the study staff are excluded:

• Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
• Clinically relevant allergic symptoms.
• Detection of alcohol at the time of initial examination (day SC) or on any study (positive alcohol test) or by case history.
• Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
• Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
• Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
• Smoking in the study center on study days A, B, C and D.
• Participation in another clinical trial within the last 60 days.
• Bad compliance.
• Cancellation of informed consent.

Related Conditions & MeSH terms

• Brain Waves

Intervention

Dietary Supplement:
• HRG80 Hydroponic Red Ginseng
Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides
• Conventional White Ginseng
Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides
• Placebo
Visually identical placebo capsule containing rice flour

Locations

Country	Name	City	State
Germany	Clinical Labors of NeuroCode AG	Wetzlar

Sponsors (1)

Lead Sponsor	Collaborator
EuroPharma, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo	Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: d2-test for attention (d2-Test).	Four weeks
Primary	Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo	Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: memory test (ME-Test).	Four weeks
Primary	Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo	Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: concentration-performance-test with financial reward (CPT-Test).	Four weeks