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

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

101

Baseline Characteristics International Group Median age: 75, Gender:23 males (46.9%), Median MMSE score: 29, Median ABC Dementia Scale score: 114 Placebo Group Median age: 74, Gender:25 males (48.1%), Median MMSE score: 29, Median ABC Dementia Scale score: 114

The trial commenced in December 2022, with the first patient enrolled in June 2023. By March 31, 2024, 101 patients had been enrolled and assigned to the test food group (n=49) and the placebo group (n=52). By the end of the observation period, 3 patients in the test food group and 2 patients in the placebo group had discontinued.

Nineteen adverse events and nine changes in blood test values were reported, but none were suspected to be related to this study. No deaths or other serious adverse events occurred.

Primary Outcome: No significant difference was observed between groups in the change in MMSE scores (0.4 vs 0.4, P=0.897). Secondary Outcome: No significant differences were observed between groups in the change in individual MMSE item scores, the ABC Dementia Scale total score, or the change in individual classification scores.

This study did not demonstrate a clear cognitive-enhancing effect of Korean ginseng. However, factors such as the sensitivity of the evaluation metrics, subject characteristics, and intervention duration may have made it difficult to detect potential effects. Re-evaluation is warranted through the introduction of more sensitive assessment methods, long-term observation, subject selection considering stratification, and design modifications to minimize placebo effects.

April. 02, 2026

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs051220129

Kitamura Akihiro

Shiga university of medical science

Tsukinowa-cho, Otsu, Shiga

yutakuto@belle.shiga-med.ac.jp

Asada Megumi

Shiga university of medical science

Tsukinowa-cho, Otsu, Shiga

+81-77-548-2160

ginseng-ml@belle.shiga-med.ac.jp

Complete

Dec. 09, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(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

(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.

Both

Healthy subjects who are concerned about forgetfulness (including MCI)

taking either a food containing red ginseng maturation extract or a placebo for 24 weeks.

Healthy aging,forgetfulness

Internal medicine

Healthy aging

Amount of change in MMSE from screening test to final inspection

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

+81-77-548-3576

Nov. 10, 2022

none