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

Phase 4

Completed

• Conditions: Brain Waves
• Interventions: Dietary Supplement: HRG80 Hydroponic Red Ginseng; Dietary Supplement: Conventional White Ginseng; Dietary Supplement: Placebo

• Registration Number: NCT04167449
• Lead Sponsor: EuroPharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-18
• Primary Completion: 2020-03-30
• Study Completion: 2020-05-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydroponic Red Ginseng	HRG80 Hydroponic Red Ginseng	-
Conventional White Ginseng	Conventional White Ginseng	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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: concentration-performance-test with financial reward (CPT-Test).

Trial Locations

Locations (1)

Clinical Labors of NeuroCode AG; 🇩🇪 Wetzlar, Germany