The Efficacy and Safety of KD501 on Memory Improvement
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004424
- Lead Sponsor
- Wonkwang University. Iksan Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Adult male and female aged 20 years or older and 65 years old, complaining of memory degradation
2) Those who can read Korean literature
3) K-WMS-IV's simplified recognition status test results are above the boundary line, and those with an auditory memory index or visual memory index of 85 or lower, or those with an SVLT or RCFT score of SNSB-II compared with the same age and education level (immediately count of points or number of delayed recovery points).
4) A person who agrees to participate in the human application test before the start of the human application test and prepared a written consent form
1) Those who are hospitalized for malignancy, severe cerebrovascular diseases (such as cerebral infarction, cerebral hemorrhage, etc.) or severe heart disease (an arrhythmia requiring unstable angina, myocardial infarction, and heart failure) or who have not passed three months since discharge from hospitalization
2) Those who are currently suffering from schizophrenia or have a history
3) Current DSM-V major depression disorder.
4) A person who has 16 or more points of depression according to CES-D test results
5) Those with diseases that are accompanied by a decrease in cognitive function, such as dementia, Parkinson's and cerebral infarction (the criteria for dementia diagnosis are based on DSM-V.)
6) Visit 1 Persons with experience in administering estrogen replacement therapy (excluding local application agents) within two months of standard visit1
7) Anyone who has experience in administering medications (alarm credit, degenerative disease solvents, brain function improvement, and tricyclic antidepressants) that can affect cognitive function or memory improvement within four weeks of visit1;
8) Those who have taken health function foods related to improvement of cognitive function or memory within two weeks of visiting 1;
9) Those with a daily dose of vitamin E of 400 IU or more are expected to decrease the dose;
10) Alcohol abuse and heavy reliance on alcohol
11) Patients with thyroid disease below 0.1µU/ml or above 10µU/ml of TSH
12) A person whose creatine is twice the test institution's normal upper limit
13) A person whose AST (GOT) or ALT (GPT) is three times the test institution's normal upper limit
14) Unregulated hypertension patients (based on measurement after 10 minutes of stabilization of those subject to the human application test)
15) Unregulated diabetic patients (over 180 mg/dl per empty blood)
16) Those who are pregnant, nursing, or planning to conceive within three months;
17) A person who has participated in another interventional clinical test (including a human application test) within three months of the commencement of this human application test or plans to participate in another interventional clinical test (including a human application test) after the start of this human application test;
18) Those who are deemed unfit for the human application test by the tester;
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Computerized NeuroCognitive Function Test;Digit Span Test;Korean Wechsler Memory Scale-Fourth Edition;Brain-Derived Neurotrophic Factor, Interleukin-6
- Secondary Outcome Measures
Name Time Method Seoul Neuropsychological Screening Battery