Research on Memory Improving Effect and Safety of Korean Dandelion (Taraxacum coreanum) and Safflower (Carthamus tinctorius L.) Seed Extract: Study Protocol for Clinical Trial
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004436
- Lead Sponsor
- ational Institute of Horticultural and Herbal Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
Men and women aged 45-70 years; Degree of over an elementary school or higher; K-MAS (Korean version of memory assessment scales) standard score ? 86; Anxiety or depression subscale score of HADS (Hospital Anxiety and Depression Scale) ?10; Those who can be followed up during clinical trial; Those who decide to participate voluntarily in this clinical trial and agree to comply with the precautions and give informed consent
Patients who have been treated or have medical history of neurodegenerative diseases (dementia, Parkinson's disease, etc.), head trauma, stroke, etc. that may affect memory; Those who have taken medicines or health functional foods that may affect memory within 4 weeks of screening; Those who have hypersensitivity reactions such as allergies to test foods; Liver cancer or liver cirrhosis, chronic renal failure, congestive heart failure, etc .; Those taking medicines (antihistamines, nonsteroidal anti-inflammatory drugs, corticosteroids, antibiotics, decongestants, etc.) that may affect the interpretation and evaluation of results; Those who have medication use due to hypothyroidism or hyperactivity within 1 year of the screening day (those who are considered to be able to participate in this test by the tester can participate); Patients with a history of severe migraine within 1 year of screening date, a history of thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty; Depression, and anxiety disorders, or are currently taking psychotropic drugs such as antidepressants; People with diabetes whose blood sugar is unregulated (fasting blood sugar over 180mg/dL or started new drug due to diabetes within 3 months); Drugs or alcoholics; ALT (Alanine transaminase) or AST (Aspartate transaminase) is more than 2.5 times the normal upper limit of the laboratory test; Creatinine exceeds 2.5 times the normal upper limit of the laboratory test; Those who have participated in other clinical trials within one month or are planning to participate in other clinical trials during the trial period; Women (pregnant, lactating, fertile woman) who are not performing appropriate contraceptive methods (hormone contraceptive: oral contraceptive device, intrauterine contraceptive device: loop, contraceptive method: femidom, vaginal spermicide); Those who are accommodated in social facilities such as social welfare facilities; Those who have difficulty communicating due to sight and hearing disabilities or difficult to handwrite due to physical disabilities; Those with previous history of general anesthesia within the last 3 months; And for any other reason, those whom the research director consider ineligible to participate in the clinical trial shall be excluded from the subject.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in the global memory scale score of Korean version of memory assessment scales (K-MAS)
- Secondary Outcome Measures
Name Time Method change in the short-term memory summary score of Korean version of memory assessment scales (K-MAS);change in the verbal memory summary scale score of Korean version of memory assessment scales (K-MAS);change in the visual memory summary scale score of Korean version of memory assessment scales (K-MAS);change in the amount of ß-amyloid protein