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

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

Sponsors

Lead Sponsor: EuroPharma, Inc.

Source 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.

Overall Status Completed
Start Date November 1, 2019
Completion Date May 1, 2020
Primary Completion Date March 30, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure 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 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 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 Four weeks
Enrollment 16
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: HRG80 Hydroponic Red Ginseng

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

Arm Group Label: Hydroponic Red Ginseng

Intervention Type: Dietary Supplement

Intervention Name: Conventional Red Ginseng

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

Arm Group Label: Conventional Red Ginseng

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Visually identical placebo capsule containing rice flour

Arm Group Label: Placebo

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.

Gender: All

Minimum Age: 60 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Wilfried Dimpfel, PhD Principal Investigator NeuroCode AG
Location
Facility: Clinical Labors of NeuroCode AG
Location Countries

Germany

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Hydroponic Red Ginseng

Type: Active Comparator

Label: Conventional Red Ginseng

Type: Active Comparator

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov