Effect of Crataegus pinnatifida Bunge extract on the Safety and Memory Improvement ; A Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003207
- Lead Sponsor
- OKCHUNDANG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
1. Males and females 45 =age = 65
2. Those with elementary school or higher education
3. Subjects whose MQ(Memory Quotient) score in Rey-Kim memory test is 70 or more, but less than 120.
4. Subjects who after listening carefully and fully understanding this clinical trial, has decided to participate voluntarily and has agreed in writing to observe the cautions.
5. Subjects who are possible to follow up during the trial period.
6. Subjects whose depression or anxiety subscale score in HADS(Hopital Anxiety and Depression Scale) is less than 8.
7. Subjects who doesn’t meet the exclusion criteria
1. Subjects with physical diseases which can affect memory such as neurodegenerative diseases like dementisa, Parkinson disease, traumatic brain injury, stroke.
2. Subjects who have taken any medicines or dietary supplements which can affect memory within 4 weeks.
3. Subjects who have allergic reaction or hypersensitive reaction to experimental supplement.
4. Subjects who have hepatoma, liver cirrhosis, chronic renal failure, congestive heart failure.
5. Subjects who have been taking antihistaminic agent, nonsteroidal antiinflammatory drug, steroid, antibiotics, decongestant.
6. Subjects who have been taking any medicine to treat hyperthyroidism or hypothyroidism within 1 year.(Subjects who investigators decided to be possible to participate to this trial can be involved.)
7. Subjects who have severe migraine, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina pectoris, or PTCA within 1 year.
8. Subjects who have mental disorders like depression, anxiety disorders, or been taking any antidepressants, antipsychotics agents.
9. Subjects who have uncontrolled diabetes mellitus. (FBT = 80mg/dL or Subjects who started new hypoglycemic agents withing the last 3 months)
10. Subjects who have history of drug or alcohol dependency or abuse.
11. ALT(Alanine transaminase) or AST(Aspartate transaminase) > 2.5 times compared to the normal upper limit in research institute.
12. Creatinine > 2.5 times compared to the normal upper limit in research institute.
13. Subjects who participated in another clinical study in the last 30 days or plan to participate in another clinical study.
14. Subjects who are pregnancy, breast feeding, or females of childbearing potential who are not practicing acceptable pregnancy prevention methods.
15. Subjects who are institutionalized in group facilities like social welfare organs.
16. Subjects who have difficulty of communication or writing due to visual, auditory, physical impairment.
17. Subjects who are not appropriate by investigator’s decision.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rey-Kim memory test MQ(Memory Quotient)
- Secondary Outcome Measures
Name Time Method Rey-Kim memory test K-AVLT(the Korean-Auditory Verbal. Learning Test) learning curve, Memory retention, retrieval efficiency;Rey-Kim memory test K-CFT(the Korean-Complex Figure Test);The change of digit span assessment score;ß-amyloid protein