KCT0004424招募中未知
A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KD501 on Memory Improvement
Wonkwang University. Iksan Korean Medicine Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- 20(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Adult male and female aged 20 years or older and 65 years old, complaining of memory degradation
- •2) Those who can read Korean literature
- •3) K-WMS-IV's simplified recognition status test results are above the boundary line, and those with an auditory memory index or visual memory index of 85 or lower, or those with an SVLT or RCFT score of SNSB-II compared with the same age and education level (immediately count of points or number of delayed recovery points).
- •4) A person who agrees to participate in the human application test before the start of the human application test and prepared a written consent form
排除标准
- •1) Those who are hospitalized for malignancy, severe cerebrovascular diseases (such as cerebral infarction, cerebral hemorrhage, etc.) or severe heart disease (an arrhythmia requiring unstable angina, myocardial infarction, and heart failure) or who have not passed three months since discharge from hospitalization
- •2) Those who are currently suffering from schizophrenia or have a history
- •3) Current DSM-V major depression disorder.
- •4) A person who has 16 or more points of depression according to CES-D test results
- •5) Those with diseases that are accompanied by a decrease in cognitive function, such as dementia, Parkinson's and cerebral infarction (the criteria for dementia diagnosis are based on DSM-V.)
- •6) Visit 1 Persons with experience in administering estrogen replacement therapy (excluding local application agents) within two months of standard visit1
- •7) Anyone who has experience in administering medications (alarm credit, degenerative disease solvents, brain function improvement, and tricyclic antidepressants) that can affect cognitive function or memory improvement within four weeks of visit1;
- •8) Those who have taken health function foods related to improvement of cognitive function or memory within two weeks of visiting 1;
- •9) Those with a daily dose of vitamin E of 400 IU or more are expected to decrease the dose;
- •10) Alcohol abuse and heavy reliance on alcohol
- •11) Patients with thyroid disease below 0.1µU/ml or above 10µU/ml of TSH
- •12) A person whose creatine is twice the test institution's normal upper limit
- •13) A person whose AST (GOT) or ALT (GPT) is three times the test institution's normal upper limit
- •14) Unregulated hypertension patients (based on measurement after 10 minutes of stabilization of those subject to the human application test)
- •15) Unregulated diabetic patients (over 180 mg/dl per empty blood)
- •16) Those who are pregnant, nursing, or planning to conceive within three months;
- •17) A person who has participated in another interventional clinical test (including a human application test) within three months of the commencement of this human application test or plans to participate in another interventional clinical test (including a human application test) after the start of this human application test;
- •18) Those who are deemed unfit for the human application test by the tester;
研究者
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