KCT0003695已完成未知
Effect of WS-5 on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Chung-Ang Univerisity Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 55(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Adult men and women aged from 55 t0 85 years old who complain memory loss
- •2) Those who can decipher Korean
- •3) CERAD-K memory score decreased from 1.0SD to less than 2.0SD compare to the same age and education level gruop (CERAD word list memory or word delayed recall or word recognition)
- •4) A person who agrees to participate in the test and has signed an informed consent form
排除标准
- •1) A person who is admitted to hospital with malignant tumor, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe heart disease (unstable angina, myocardial infarction, arrhythmia requiring heart failure treatment) or 3 months after discharge
- •2) According to DSM-V, a person with major depressive disorder or epidemic disease, or alcohol dependence
- •3) A person with disease causing cognitive impairment such as dementia, Parkinson's disease, etc.
- •(The criteria for diagnosing dementia are based on DSM-V.)
- •4) A person who has experience of administering drugs (antipsychotic drugs, degenerative disease agents, brain function improvers, tricyclic antidepressants) for dementia or other cognitive dysfunction within 4 weeks
- •5) A person whose daily dose of vitamin E preparation is 400 IU or more, or whose dosage decreasing is inevitable.
- •6) A person who have received estrogen replacement therapy (excluding topical application agents) within 2 months of the start of the test
- •7) A person who took a healthy functional food related to improvement of cognitive function within 2 weeks
- •8) Patients with thyroid disease with TSH less than or equal to 0.1 uU / ml or greater than or equal to 10 uU / ml
- •9) A person whose creatinine level is more than twice the normal upper limit of the testing laboratory.
- •10) A person whose AST (GOT) or ALT (GPT) level is more than three times the normal upper limit of the testing laboratory.
- •11) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization)
- •12) Diabetic patients whose blood sugar is not controlled (fasting blood sugar 180mg / dl or more)
- •13) A person who is pregnant, lactating or planning pregnant within 3 months.
- •14) A person who has participated in another clinical test within 3 months from the start of this test, or who plans to participate in another clinical test after the start of this test
- •15) Any person deemed inappropriate by the tester
- •16) A person with depression whose SGDS score is 8 or more
研究者
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