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An observational study of herbal medicine treatment in Mild Cognitive Impairment and Mild Dementia patients

Not Applicable
Recruiting
Conditions
Mental and behavioral disorders
Registration Number
KCT0004799
Lead Sponsor
Dunsan Korean Medicine Hospital of Daejeon University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

1. Men and women aged 45 to under 85
2. A person diagnosed with major or mild neurocognitive impairment based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria
3. When Clinical Dementia Rating is 0.5 and corresponds to Global Deterioration Scale 2-5
4. Those who have 22 or less Korean Version of Montreal Cognitive Assessment points
5. A person who can understand the questionnaire directly or through his or her next of kin
6. A person who voluntarily agreed to a clinical research agreement by the subject or his or her legal representative

Exclusion Criteria

1. If there are cranial lesions, brain damage, or mental retardation that may impair cognitive function.
2. Have a history of brain diseases such as Huntington's disease, normal hydrocephalus, or brain tumor
3. Have gastrointestinal, endocrine and cardiovascular diseases that are not controlled by diet or medication
4. Diabetics who are not controlled by hypoglycemic agents or who have diabetes not controlled by insulin, etc.
5. If you have severe liver disease or kidney disease enough to receive kidney dialysis
6. Anemia, hypothyroidism, vitamin deficiency, malignant disease
7. In severely unstable medical conditions (based on the results of clinical laboratory tests, Electrocardiogram, Chest X-ray, vital signs, etc.)
8. Have a history of major psychiatric disorders diagnosed by Diagnostic and Statistical Manual of Mental Disorders-5, for example, schizophrenia, delusional disorder, depressive disorder, bipolar disorder, alcohol or substance use disorder
9. Have experience in other clinical trials with intervention in the last 4 weeks
10. Females of childbearing age
11. If you do not understand the consent form or have difficulty researching due to mental retardation, emotional or intellectual problems
12. Difficulties due to blindness, hearing loss or severe speech disorder
13. If you are not eligible to participate in this clinical study at the discretion of the researcher.

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Seoul Neuropsychological Screening Battery
Secondary Outcome Measures
NameTimeMethod
Korean Version of Montreal Cognitive Assessment;Neuropsychiatric Inventory–Questionnaire;EuroQol-5 dimension;Pattern Identifications Tool for Cognitive Disorders;Body Mass Index;Integrative Medicine Patient Satisfaction Scale;Electroencephalography 
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