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Completed

NCT Number: NCT04167449

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

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.

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Key information

Conditions

Brain Waves

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Labors of NeuroCode AG

Wetzlar, D-35578, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRG80 Hydroponic Red Ginseng

Dietary Supplement

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

Conventional White Ginseng

Dietary Supplement

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

Placebo

Dietary Supplement

Visually identical placebo capsule containing rice flour

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

    Time frame: Four weeks

    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).

  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

    Time frame: Four weeks

    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).

  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

    Time frame: Four weeks

    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).

Sponsors and collaborators

Lead sponsor

EuroPharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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