None listed
Conditions
Interventions
Dietary Supplement : Subjects will take one capsule (300mg) of the IP(containing CKDB001) twice daily at suitable times with sufficient water for 12 weeks, starting from the day after randomization. S
Sponsors
Chong Kun Dang Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals who have voluntarily given written informed consent after receiving sufficient explanation about this human application trial. 2) Adult men and women aged 55 to less than 80 years as of the date of written consent. 3) Individuals who are capable of understanding Korean. 4) Individuals whose score on the SVLT-E of the SNSB-II is decreased by more than 1.0 SD but less than 2.0 SD compared to the normal standard for the same education level and age group.
Exclusion criteria
Exclusion criteria: - Individuals with any of the following medical histories or surgical/procedural histories: diseases accompanied by cognitive impairment, history of mental illness that may affect this human application trial, history of infections affecting brain function, severe concomitant diseases/disabilities deemed unsuitable for study participation by the researcher, etc. - Individuals who have taken the following drugs and food within 4 weeks of Visit 2 (Baseline): those who have been administered or are expected to be administered during the study period drugs that can affect cognitive function, those who have continuously consumed or are expected to consume health functional foods or dietary supplements related to cognitive and memory improvement, etc. - Individuals with hypersensitivity to any component of the test food or other allergies deemed unsuitable for study participation by the researcher's opinion. - Pregnant or breastfeeding women. - Women of childbearing potential and men who are unwilling or unable to use appropriate contraception methods during the study period. - Individuals who have participated in another study involving clinical trial drugs, foods, or medical devices within the past 3 months. - Any other reasons deemed by the researcher as inappropriate for conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total ADAS-cog-13 score at 12 weeks compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in DST (Digit Span Test) score at 12 weeks compared to baseline.;Change in TMT (Trail Making Test) score at 12 weeks compared to baseline.;Change in Stroop Test score at 12 weeks compared to baseline.;Change in Cytokine levels at 12 weeks compared to baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Cheon Joo
Wonkwang University Oriental Medical Hospital, Jeonju
Outcome results
None listed