None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to either the Gastrodia elata extract group or the placebo group and will orally consume the assigned product once daily for 12 weeks.
• Gastro
Sponsors
Wonkwang University. Iksan Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who complain of subjective memory loss {one or more points in the subjective memory loss questionnaire (SMCQ)} 2) Subjects not meeting the clinical diagnostic criteria fors Attention-Deficit Hyperactivity Disorder(ADHD) 3) Subjects not meeting the diagnostic criteria for dementia according to the Diagnostic and Statistical Manual of Mental Disorders(DSM) 4) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions.
Exclusion criteria
Exclusion criteria: 1) Subjects with abnormal findings in blood tests - ALT or AST = 3 times the upper limit of normal - Hb = 8 g/dL or platelet < 100,000/mm³ - eGFR < 60 mL/min/1.73 m² 2) Subjects with cognitive impairment due to neurological or psychiatric disorders 3) Subjects with uncontrolled hypertension 4) Subjects with uncontrolled diabetes mellitus 5) Subjects with thyroid-stimulating hormone (TSH) levels outside the normal range of the study institution 6) Subjects with severe psychiatric disorders such as major depression, schizophrenia, alcoholism, or drug dependence 7) Subjects with a history of unstable angina, myocardial infarction, transient ischemic attack, or coronary intervention including coronary artery bypass graft surgery within 6 months prior to the date of consent 8) Subjects with a history of severe head trauma accompanied by loss of consciousness within 6 months prior to the date of consent 9) Subjects with a history of acute stroke within 3 months prior to the date of consent 10) Subjects with severe hearing or visual impairment that makes efficacy evaluation impossible 11) Pregnant or lactating women, or those planning to become pregnant during the study period 12) Subjects with known allergy or hypersensitivity to the investigational product 13) Subjects with excessive alcohol consumption 14) Subjects with excessive smoking 15) Subjects who have taken health functional foods related to the study outcome within 3 months prior to screening 16) Subjects who have participated in another clinical trial within 3 months prior to screening 17) Subjects deemed unsuitable for study participation by the principal investigator due to clinical laboratory results or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean Version of Montreal Cognitive Assessment (MoCA-K)(Visuospatial/Executive function, Language, Attention, Sentence repetition, Abstraction, Delayed recall, Orientation, Total score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum interleukin-6 (IL-6);Digit Span Test in Computerzied NeuroCognitive Function test(Forward span length, Forward T/P score, Backward span length, Backward T/P score);Korean Mini-Mental Status Examination(Orientation to time, Orientation to place, Registration, Attention&calculation, Recall, Language, Drawing, Total score);Brain-derived neurotrophic factor(BDNF) | — |
Countries
Korea, Republic of
Contacts
Public ContactAerin
Wonkwang University. Iksan Korean Medicine Hospital
Outcome results
None listed