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

EuroPharma

Status and phase: Completed; Phase 4

Conditions: Brain Waves

Treatments: Dietary Supplement: HRG80 Hydroponic Red Ginseng; Dietary Supplement: Conventional White Ginseng; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04167449

EP-1006

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Hydroponic Red Ginseng

Active Comparator group

Treatment:

Dietary Supplement: HRG80 Hydroponic Red Ginseng

Conventional White Ginseng

Active Comparator group

Treatment:

Dietary Supplement: Conventional White Ginseng

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo