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CompletedNCT04167449Updated Feb 16, 2021

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

A Phase 4 interventional study of HRG80 Hydroponic Red Ginseng and Conventional White Ginseng in Brain Waves, sponsored by EuroPharma, Inc.. Completed at 1 site in Germany. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by EuroPharma, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Waves
03

In context

Lead sponsor

EuroPharma, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Hydroponic Red Ginseng

    Dietary Supplement: HRG80 Hydroponic Red Ginseng

  • Active comparator
    Conventional White Ginseng

    Dietary Supplement: Conventional White Ginseng

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementHRG80 Hydroponic Red Ginseng

    Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides

  • Dietary supplementConventional White Ginseng

    Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides

  • Dietary supplementPlacebo

    Visually identical placebo capsule containing rice flour

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Four weeks

  2. 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).

    Time frame: Four weeks

  3. 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).

    Time frame: Four weeks

07

Study locations

1 site
  • Clinical Labors of NeuroCode AG
    Wetzlar, D-35578, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04167449
Lead sponsor
EuroPharma, Inc.
Responsible party
Sponsor
First posted
Nov 18, 2019
Start date
Nov 1, 2019
Primary completion
Mar 30, 2020
Completion
May 1, 2020
Last update
Feb 16, 2021

Study contacts

Wilfried Dimpfel, PhD
principal investigator · NeuroCode AG

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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