None listed
Conditions
Interventions
Dietary Supplement : take a capsule containing steamed and freeze-dried mature silkworm/Angelica gigas extract (SWA-1 )or placebo for 24weeks,
- Three times a day, 3capsuls(1cap:389.224mg)/time
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects who agree to participate in this study and have given their written informed consent 2)Mild Cognitive Impairment (Those with Consortium to Establish a Registry for Alzheimer's Disease-Korea total score equal to or lower than 1.0SD when compared to the educational level and age group)Men and women aged 50 to over 80, except illiterate with symptoms 3)When the CERAD-K total score is compared with the same level of education and age Those who are in the range of less than 1.0SD to less than 5% of the range. 4)Those who do not meet the definition of dementia in the Diagnostic and Statistical Manual of Mental Disorders(Diagnostic and Statistical Manual of Mental Disorders 5, DSM-5).
Exclusion criteria
Exclusion criteria: 1)Test subjects who experienced adverse reactions such as allergies when taking health functional foods and medicines 2)Subjects who were diagnosed with dementia, brain tumor, and hydrocephalus 3)who have gastrointestinal or psychiatric history or are currently suffering from the disease(such as schizophrenia, epilepsy, alcoholism, anorexia, anorexia nervosa, etc.) 4) Stroke, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, narrow angle glaucoma, uncontrolled hypertensive subjects(160 / 100mmHg or more, after 10 minutes of stabilization) or subjects with lung disease 5)Test subjects with severe renal impairment or liver dysfunction serum creatinine > 2.0 mg/dl, ALT, AST, alkaline phosphatase >Normal upper limit x 2.5) 6)If blood sugar is difficult to control with a hypoglycemic agent (more than 160 mg / dL of fasting glucose even though you are taking a hypoglycemic agent), Subjects with a hemoglobin level (male: 9.5 g / dL, female: 9.0 g / dL) 7)Have experienced oral corticosteroids, thyroid hormone, etc. or have taken medications or functional foods that affect the absorption, metabolism and excretion of test food within the last 3 months, or have experience in other human application tests within 3 months Subject 8) Subjects who have undergone surgical operation within 6 months or have been banned within 1 month (treatment for acupuncture or brain function improvement or medication with health food or abuse) 9) Subjects who underwent surgery to influence the absorption of drugs, such as gastrectomy 10) Women who do not consent to the choice of pregnant, lactating and appropriate methods of contraception (oral contraceptives, hormonal implants, intrauterine devices, condoms, spermicides) 11) Test subjects who donated blood within the last 2 months or blood donated within 1 month 12) According to the opinion of the person in charge of testing applied to human body, the person who is judged to be unable to comply with the test,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s Disease Assessment Scale - Cognition total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Alzheimer’s Disease Assessment Scale - Cognition Memory Factor;Verbal Fluency Test:Category fluency;Digit Span Test;The Short Cued Recall Test;Enhanced Cued Recall Task | — |
Countries
Korea, Republic of
Contacts
Public ContactWON SUB KANG
Kyung Hee University Hospital
Outcome results
None listed