Clinical trial NCT04167449: Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Waves
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Four weeks
measure: 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
timeFrame: Four weeks
measure: 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
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wetzlar
country: Germany
facility: Clinical Labors of NeuroCode AG
Study officials:
affiliation: NeuroCode AG
name: Wilfried Dimpfel, PhD
role: PRINCIPAL_INVESTIGATOR
References: