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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Brain Waves

Intervention / Treatment
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* Dietary Supplement: HRG80 Hydroponic Red Ginseng
* Dietary Supplement: Conventional White Ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |