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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Waves
• Intervention / Treatment: Dietary supplement: HRG80 Hydroponic Red Ginseng; Dietary supplement: Conventional White Ginseng; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Wetzlar, Germany, D-35578
    • Clinical Labors of NeuroCode AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Visually identical placebo capsule containing rice flour
Active Comparator: Hydroponic Red Ginseng	Dietary supplement: HRG80 Hydroponic Red Ginseng; Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides
Active Comparator: Conventional White Ginseng	Dietary supplement: Conventional White Ginseng; Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: EuroPharma, Inc.
• Investigators: Principal Investigator: Wilfried Dimpfel, PhD, NeuroCode AG

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EP-1006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No