A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of OFE on Memory Improvement of Adolescent
- Conditions
- Not Applicable
- Registration Number
- KCT0008170
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 56
1) Teenagers over 12 years of age and under 18 years of age
2) A person who can read and read the Korean language
3) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
1) Person who scored 30 points as a result of MoCA-K in Visit 1
2) Persons diagnosed with intellectual disability or ADHD
3) A person diagnosed with a psychiatric disease that may affect cognitive function;
4) A person who has taken neuropsychiatric medication within 4 weeks based on visit 1
5) A person who has taken medication or health functional food related to memory improvement within 4 weeks based on visit 1.
6) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for those subject to human application tests)
7) Patients with uncontrolled diabetes (above 180 mg/dL of fasting blood sugar)
8) an uncontrolled thyroid patient
9) Those with a creatine level of at least twice the normal upper limit of the implementing institution.
10) Those whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the agency.
11) A person who has participated in another interventional clinical trial (including the human body application test) within 3 months of visit 1 or plans to participate in another interventional clinical trial (including the human body application test) after the start of this human body application test
12) A person who is sensitive to or allergic to food ingredients for human application tests
13) A person who the tester deems inappropriate for this human body application test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MQ score, immediate recovery index, delayed recovery index, qualitative score of Rey-Kim memory test
- Secondary Outcome Measures
Name Time Method MoCA-K Total Score;Digit Span Test