Asian ginseng for improvement of cognitive function in healthy Japanese elderly including minimal cognitive impairment (MCI)

JRCT ID: jRCTs051220129

Registered date:09/12/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects who are concerned about forgetfulness (including MCI)
• Date of first enrollment: 09/12/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): taking either a food containing red ginseng maturation extract or a placebo for 24 weeks.

Outcome(s)

• Primary Outcome: Amount of change in MMSE from screening test to final inspection

Secondary Outcome

Amount of change in the following items from the screening baseline test to the interim test
1) MMSE item scores
2) ABC-Dementia Scale total score
3) Score for each category of the ABC Dementia Scale

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) 65 years old and over
(2) 22 or higher on MMSE (Mini-Mental Examination)
(3) Accompanied by study partner
(4) Written informed consent for participation in this study has been obtained

Exclude criteria

(1) With vision or hearing impairment that interferes with cognitive function tests
(2) Taking functional foods, health foods, etc. claiming to keep cognitive function
(3) Taking drugs with effects and indications related to dementia
(4) Taking warfarin potassium
(5) Have teken the health food "Shinpi no Kenkouryoku GOLD"
(6) With a hypersensitivity to Korean ginseng
(7) Taking other medicines or foods containing ginseng
(8) Deemed ineligible by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Kitamura Akihiro
• Source(s) of Monetary Support: KIM's Korean Ginseng Co.,Ltd.