Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function

Chonbuk National University

Status

Completed

Conditions

Cognitive Function

Treatments

Dietary Supplement: Hydrolysed Red Ginseng Extract

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04184388

IH-CF-HRGE

Details and patient eligibility

About

This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function

Full description

This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.

Enrollment

100 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Persons who are at least 60 years of age at screening
Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion criteria

Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
Patients with alcohol abuse or dependence within the last 3 months
Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng
Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
Patients who ingested ginseng and red ginseng extract's health functional food within 1 month before screening
Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
Patients who participate in another human trial within 3 months
Those who show the following results in the Laboratory test
- AST, ALT > 3 times upper limit of the normal range
- Other significant laboratory test opinion
Patients who are deemed unsuitable for participating in the human trial due to other reasons