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

NCT04167449 | Completed Phase 4

• 1 other identifier: EP-1006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Waves

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Hydroponic Red Ginseng

ACTIVE COMPARATOR

Dietary Supplement: HRG80 Hydroponic Red Ginseng

Conventional White Ginseng

ACTIVE COMPARATOR

Dietary Supplement: Conventional White Ginseng

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

HRG80 Hydroponic Red Ginseng DIETARY_SUPPLEMENT

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

Hydroponic Red Ginseng

Conventional White Ginseng DIETARY_SUPPLEMENT

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

Conventional White Ginseng

Placebo DIETARY_SUPPLEMENT

Visually identical placebo capsule containing rice flour

Placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• EuroPharma, Inc.: lead

Study Sites (1)

Clinical Labors of NeuroCode AG

Wetzlar, D-35578, Germany

Location

Study Officials

• Wilfried Dimpfel, PhD

  NeuroCode AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 18, 2019
• Study Start: November 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 1, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

DE (1)