A randomized, double-blinded, control comparative human application test to analyze the effect of oral ingestion of pig brain enzyme hydrolase on memory improvement
- Conditions
- Not Applicable
- Registration Number
- KCT0009426
- Lead Sponsor
- Cheonan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
1. Men and women aged 45 to 70 as of the screening date
2. a person who has graduated from elementary school or higher
3. Those with a standard score of 86 or higher in the Korean version of the Memory Evaluation Test (K-MAS)
4. A person who, having heard and fully understood the detailed explanation of this human body test, voluntarily decides to participate and agrees in writing to comply with the precautions
5. A person who can be followed up during the human body test period
6. A person with a sub-scale score of 10 or less for anxiety or depression on the HADS (Hospital Anxiety and Depression Scale)
7. A person who is not included in the exclusion criteria
1. A person who is undergoing treatment or has a medical history of physical diseases such as neurodegenerative diseases (dementia, Parkinson's disease, etc.), head trauma, stroke, etc. that may affect memory
2. A person who has had the experience of taking medicines or health functional foods that may affect memory within four weeks from the screening date
3. A person who has a hypersensitivity reaction, such as allergies, to the food for testing
4. A person who is being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc
5. A person who is taking drugs (antihistamines, nonsteroidal anti-inflammatory drugs, adrenocortical hormones, antibiotics, antihypertensive drugs, etc.) that may affect the interpretation and evaluation of the results
6. A person who has a history of taking drugs due to hypothyroidism or hyperactivity within one year from the screening date (Those who are deemed by the tester to be able to participate in this test can participate)
7. A person who has severe migraines within one year as of the screening date, has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or has a history of coronary angioplasty
8. A person who has severe mental illness such as depression or anxiety disorder, or is currently taking mental nervous system drugs such as antidepressants
9. Diabetic patients whose blood sugar is not controlled (more than 180 mg/dL of fasting blood or starting anew due to diabetes within 3 months)
10. a drug or alcohol addict
11. ALT (Alanine transaminase) or AST (Aspartate transaminase) in excess of 2.5 times the upper limit of the operator
12. A person whose creatine exceeds 2.5 times the normal upper limit of the research institute
13. Those who have participated in other clinical trials within one month of the commencement of this trial or are planning to participate in other clinical trials during the trial period
14. A woman who has not implemented appropriate contraception (hormone contraceptives: oral contraceptives, etc., intrauterine contraceptives: loop, etc., blocking contraception: femidome, intravenous control, etc.) among pregnant women, lactating women who are likely to become pregnant
15. Persons housed in collective facilities such as social welfare facilities
16. A person who has difficulty in daily communication due to obstacles such as vision, hearing, etc. or who has difficulty in taking notes due to physical disabilities
17. Other persons deemed unsuitable by the tester's judgment
18. A person who has a history of surgery with general anesthesia within the last three months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the standard score of the overall memory score of the Korean version of the K-MAS
- Secondary Outcome Measures
Name Time Method Changes in the short-term memory standard score of the Korean version of the Memory Evaluation Test (K-MAS);Changes in the standard score of language memory in the Korean version of the Memory Evaluation Test (K-MAS);Changes in the standard score of visual memory in the Korean version of the Memory Evaluation Test (K-MAS);Changes in the Attention Memory Standard Score of the Korean version of the Memory Evaluation Test (K-MAS);Change in Digit Span score;Changes in ß-amyloid protein in blood;Changes in blood BDNF(Brain-derived neurotrophic factor)