None listed
Conditions
Interventions
Drug : Soonsimhwan group : take a Soonsimhwan once per day for 24weeks
Placebo group : take a plaecbo once per day for 24weeks
Sponsors
Dongshin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. participants(males and females) aged 55 to 85 2. participants who meet the Peterson diagnostic criteria for MCI, with memory impairments for at least 3 months 3. Score in Global Deterioration scale(GDS) was 2 or 3 4. Score in K-MMSE was 20-23 5. Score in MoCA-K was 0-22 6. Score in Geriatric Depression scale(GDS) was 0-18 7. fluency in language sufficient to reliably complete all study assessment 8. voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. diagnosed with Alzheimer's Disease according to the NINCDS-ADRDA or diagnosed with vascular dementia according to the NINDS-AIREN 2. history of brain structure lesions which may cause cognitive impairment(e.g., traumatic brain injury, stroke, intracranial space-occupying lesions, congenital mental retardation) 3. serious disease conditions (e.g., cancer, kidney, liver, cardiovascular , and central nervous system diseases, Parkinson's disease, Huntionton disease, and Multiple sclerosis) ; a history of brain lesions confirmed on Brain CT or MRI within 12 months 4. who had been treated with alcohol or drug dependency, mental diseases(e.g., schizophrenia, serious anxiety, and depression) in the past six months 5. current treatment for MCI, such as medication, cognitive training, or Koean medicine treatment within 4 weeks before screening 6. who have difficulties in assessment due to visual and hearing impairments 7. impaired hepatic function(ALT (GPT) or AST (GOT) is at least twice the normal upper limit of the performing center) 8. impaired renal function(creatinine is at least twice the normal upper limit of the performing center) 9. the hypertensive patient (170/100mmHg or greater) or the diabetic patient (over 180mg/dl of fasting blood glucose) 10. ineligibility for participation in the trial because of a history of gastrointestinal diseases, anorexia, nausea, and vomit that might affect the absorptionj of the trial medication, as judged by the principal investigator 11. Women who are pregnant or breastfeeding 12. a history of hypersensitivity to the components of the trial medication 13. participation in other clinical trials within 4 weeks of screening for the present study or concurrent participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean version of the Montreal Cognitive Assessment scale (MoCA-K) | — |
Secondary
| Measure | Time frame |
|---|---|
| Geriatric Depression scale(GDS);Korean Activities of Daily Living(K-ADL), Korean Instrumental Activities of Daily Living(K-IADL);European Quality of Life Five Dimension. Five Level Scale(EQ-5D-5L);Korean version of Alzheimer’s Disease Assessment Scale-cognitive subscale-3 (ADAS-K-cog 3) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Hong Kim
Dongshin University
Outcome results
None listed