KCT0012355进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Hericium erinaceus Extract Powder for the Improvement of Memory Function
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 55(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •Men and women aged 55 to 74 years.
- •Participants with a subjective memory complaints, defined as a Korean Mini-Mental State Examination(K-MMSE) score =24 and an Subjective Memory Complaints Questionnaire(SMCQ) score =1
排除标准
- •Participants with severe cerebrovascular disease (e.g., cerebral infarction or cerebral hemorrhage), cardiovascular disease (e.g., angina pectoris, myocardial infarction, heart failure, or arrhythmia requiring treatment), or malignancy within the previous 6 months. Participants with a history of cerebrovascular or cardiovascular disease who are considered clinically stable may be enrolled at the investigator's discretion.
- •Participants with a current diagnosis or history of schizophrenia.
- •Participants with a Korean Short Form Geriatric Depression Scale(SGDS-K) score of =
- •Participants with diseases associated with cognitive impairment, such as dementia, Parkinson's disease, or cerebral infarction. Dementia shall be diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) criteria.
- •Participants with a clinically significant psychiatric history or current psychiatric disorder (e.g., schizophrenia or epilepsy), or a history of alcohol or substance abuse.
- •Participants diagnosed with a neuropsychiatric disorder within 3 months prior to Visit
- •Participants who have taken medications for neuropsychiatric disorders within 4 weeks prior to Visit
- •Participants who have taken medications or health functional foods that may affect cognitive function or memory (e.g., antipsychotics, anti-dementia drugs, cognitive enhancers, or tricyclic antidepressants) within 4 weeks prior to Visit
- •Participants receiving ongoing treatment or medication for gastrointestinal disorders (e.g., gastric ulcer, chronic dyspepsia, or irritable bowel syndrome).
- •Participants with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) levels =2.5 times the upper limit of normal(ULN) at the study site.
- •Participants with serum creatinine levels =2.0 times the upper limit of normal (ULN) at the study site.
- •Participants with uncontrolled diabetes mellitus (fasting blood glucose =180 mg/dL) or uncontrolled hypertension (blood pressure =160/100 mmHg after at least 10 minutes of rest at screening).
研究者
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