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

NCT ID: NCT04167449

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hydroponic Red Ginseng

Group Type: ACTIVE_COMPARATOR

HRG80 Hydroponic Red Ginseng

Intervention Type: DIETARY_SUPPLEMENT

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

Conventional White Ginseng

Group Type: ACTIVE_COMPARATOR

Conventional White Ginseng

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Visually identical placebo capsule containing rice flour

Interventions

HRG80 Hydroponic Red Ginseng

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

Intervention Type: DIETARY_SUPPLEMENT

Conventional White Ginseng

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Visually identical placebo capsule containing rice flour

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EuroPharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried Dimpfel, PhD

Role: PRINCIPAL_INVESTIGATOR

NeuroCode AG

Locations

Clinical Labors of NeuroCode AG

Wetzlar, , Germany

Countries

Germany

Other Identifiers

EP-1006

Identifier Type: -

Identifier Source: org_study_id