An observational study of Korean herbal medicine and Electroacupuncture Combination Therapy for Mild Cognitive Impairment patients.
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0007838
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 6
1. Aged 45 to 84
2. Diagnosed with mild cognitive impairment based on DSM-5 criteria
3. Clinical Dementia Rating of 0.5
4. MoCA-K 22 points or less.
5. Patients who understand the questionnaire himself/herself or with the help of caregivers.
6. Participants who voluntarily signed an informed consent form by himself/herself or a legal representative.
1. Patients with encephalopathy, brain damage, or mental retardation that can influence cognitive function
2. Histories of brain diseases such as Huntington's disease, normal hydrocephalus, or brain tumors
3. Gastric, endocrine, or cardiovascular diseases that are not controlled by diet or medication
4. Diabetes that is not controlled by hypoglycemic agents or insulin
5. Severe liver disease or severe renal disease that requires dialysis (e.g. over 2 times the upper reference limit of AST, ALT, ?-GTP at screening)
6. Aplastic anemia or malignant disease such as cancer.
7. Seriously unstable medical conditions (the investigator will decide based on vital signs, laboratory test results, etc.)
8. Diagnosed with psychiatric disorders based on DSM-5 criteria (e.g histories of major psychiatric disorders such as schizophrenia, bipolar disorder, delusional disorder, depressive disorders, or alcohol or substance use disorder)
9. Fertile women
10. Not understand an informed consent form or hard to participate in the study due to mental retardation, emotional or intellectual issues
11. Participants with blindness, hearing loss, or severe language disorders have difficulty in examination
12. Not appropriate to participate in this study depending on decision of investigators
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Korean version of Montreal Cognitive Assessment (MoCA-K)
- Secondary Outcome Measures
Name Time Method Korean version of Alzheimer's disease assessment scale-cognitive subscale (ADAS-K-cog);Perceived Stress Scale (PSS);Beck Depression Inventory (BDI);Insomnia Severity Index (ISI);Simplified Nutritional Appetite Questionnaire (SNAQ);EuroQol-5 Dimension (EQ-5D);Integrative Medicine Patient Satisfaction Scale (IMPSS);Serum cytokine analysis