Brain Waves
Conditions
Brief 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.
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
Sponsors
EuroPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
Germany
Outcome results
None listed