KCT0004436
Recruiting
未知
Research on Memory Improving Effect and Safety of Korean Dandelion (Taraxacum coreanum) and Safflower (Carthamus tinctorius L.) Seed Extract: Study Protocol for Randomized, Double-blind, Placebo-controlled, Clinical Trial
ational Institute of Horticultural and Herbal Science0 sites84 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- ational Institute of Horticultural and Herbal Science
- Enrollment
- 84
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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