None listed
Conditions
Interventions
Dietary Supplement : One pill of Sophora japonica L. (1250mg) is orally administered one time a day, for 8 weeks
Sponsors
Kyung Hee University Oriental Medical Center
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 40 and 70 2) A person who has no difficulty in language communication, such as reading and writing Korean 3) A person whose daily life is normal but complaints of cognitive decline or forgetfulness, with a score of 0.5 or less in the Korean version of the Expanded Clinical Dementia Rating Scale (CDR) due to complaints of normal or cognitive decline or forgetfulness in daily life 4) A person who voluntarily agrees to participate in the study and signs a informed consent form.
Exclusion criteria
Exclusion criteria: 1) If the following drugs are newly prescribed or changed within 4 weeks as of the date of consent (Dementia medication, neuroprotective agents, thyroid hormone, central nervous system stimulants, antipsychotics, anticholinergics, and other psychiatric drugs) 2) Participant with abnormal findings on blood tests (AST, ALT more than 3 times the normal limit, Hb = 8 g/dL or platelet less than 100,000/mm3, Serum Creatine more than 3 times the normal limit or patients with acute or chronic renal failure requiring dialysis) 3) Participant with cognitive impairment due to brain or mental illness 4) Participant with high blood pressure, diabetes, and hypothyroidism that are not controlled by drugs. 5) Participant who has a history of unstable angina, myocardial infarction, transient ischemic attack, and coronary intervention including coronary artery bypass, within 6 months as of the date of consent 6) Participant who has a history of severe head trauma with loss of consciousness within 6 months as of the date of consent 7) Participant who has a history of acute stroke within 3 months as of the date of consent 8) Participant who takes other food or medicine for human study within one month 9) Participant who has a hypersensitivity to investigational products 10) Participant with severe hearing and vision impairments whose effectiveness assessment cannot be performed 11) Pregnant or lactating women 12) Women of childbearing potential who are not using adequate contraception (hormonal contraceptives: oral contraceptives, such as the pill; intrauterine devices: loops; barrier methods: femidom, intravaginal spermicides, etc.) 13) Participant who has difficulty communicating on a daily basis due to a disability such as visual and hearing impairment or who has difficulty taking notes due to a physical disability 14) Participant who has other upper respiratory tract infections, or chronic diseases 15) Participant with a history of surgery accompanied by general anesthesia within the last 3 months 16) Participant who is sensitive to estrogen hormones 17) Participant who is determined to be unsuitable by the investigator, such as having conditions that may affect the evaluation of the human study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CNT(Computerized Neuro-Cognitive Function Test)-Change in Digit Span Test | — |
Secondary
| Measure | Time frame |
|---|---|
| CNT(Computerized Neuro-Cognitive Function Test)-Change in other Test ;Beck Depression Inventory-Change in score; State-Trait Anxiety Inventory-Change in score;Stress Response Inventory(SRI)-Change in score;Heart Rate Variability(HRV) test change;EuroQol-5 Dimension-Change in score | — |
Countries
Korea, Republic of
Contacts
Public ContactYunna Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed