KCT0012234招募中不适用
A 12 weeks, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Moringa oleifera and Perilla frutescens extract complex on memory improvement
Cosmax Bio0 个研究点目标入组 100 人开始时间: 2026年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 50(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •(1) Male or female adults aged 50 to 70 years (inclusive) at the time of screening who complain of memory decline
- •(2) Individuals whose scores on the CERAD-K Word List Memory, Word List Recall, or Word List Recognition tests are 1 to 1.5 standard deviations (SD) below the normative mean (must meet at least one of these three criteria)
- •(3) Individuals with a total score of 22 or lower on the Korean version of the Montreal Cognitive Assessment (MoCA-K)
- •(4) Individuals who have received a detailed explanation of the clinical trial, fully understood it, voluntarily decided to participate, and provided written informed consent agreeing to comply with all precautions and instructions
排除标准
- •(1) Subjects with a history of alcohol abuse or dependence within 3 months prior to the screening visit.
- •(2) Subjects who are currently receiving treatment for major depressive disorder, have received treatment for major depressive disorder within the past 3 years, or have a Beck Depression Inventory-II (BDI-II) score =
- •(3) Subjects with diseases associated with cognitive impairment, such as dementia, Parkinson’s disease, or cerebral infarction.
- •(4) Subjects who meet the clinical diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
- •(5) Subjects who are unable to read and understand Korean.
- •(6) Subjects with known hypersensitivity to any component of the investigational product.
- •(7) Subjects with clinically significant acute or chronic diseases requiring treatment, including but not limited to disorders of the cardiovascular/cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic/neoplastic, or gastrointestinal systems.
- •(8) Subjects who have taken medications, health functional foods, or herbal medicines related to cognitive function or memory improvement within 1 month prior to screening (refer to the prohibited concomitant medications list).
- •(9) Subjects who have taken psychotropic medications, including antipsychotics, antidepressants, mood stabilizers, hypnotics, or anxiolytics, within 1 month prior to screening.
- •(10) Subjects who have donated whole blood within 1 month or undergone component blood donation within 2 weeks prior to screening.
- •(11) Subjects who have participated in another human clinical trial within 3 months prior to screening.
- •(12) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
- •(13) Subjects with any of the following laboratory findings at screening:
- •? AST or ALT > 3 × the upper limit of normal (ULN)
- •? Serum creatinine > 2.0 mg/dL
- •(14) Subjects deemed unsuitable for participation in the study by the Investigator based on laboratory test results or any other reason.
研究组 & 干预措施
Dietary Supplement : One tablet was orally administered once daily for 12 weeks.
干预措施: Dietary Supplement : One tablet was orally administered once daily for 12 weeks.
研究者
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