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

EuroPharma, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Brain Waves

Interventions

HRG80 Hydroponic Red GinsengDIETARY_SUPPLEMENT

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

Conventional White GinsengDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Visually identical placebo capsule containing rice flour

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Labors of NeuroCode AG

Wetzlar, Germany

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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