KCT0012223招募中不适用
A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Policosanol-Sugarcane Wax Alcohols for the improvement of cognitive function
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
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
- Other(This study aims to evaluate the efficacy on improvement of cognitive function and safety of Policosanol-Sugarcane Wax Alcohols.), Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
入排标准
- 年龄范围
- 55(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •Those who agree to participate in this study before the test begins and submit a completed informed consent form
- •Men and women aged 55 to under 80 years old
- •Those who complain of subjective cognitive decline
排除标准
- •Individuals suspected of having dementia as a result of a neuropsychological examination
- •Those diagnosed with any Axis I psychiatric disorder
- •Those with major medical or surgical diseases requiring immediate treatment, according to their medical history, physical examination, neurological examination, or laboratory tests
- •Individuals with contraindications to MRI
- •Individuals with the following diseases:
- •? Malignant tumors, severe cerebrovascular disease, heart disease, or neuropsychiatric disorders requiring treatment
- •? A history of traumatic brain injury accompanied by loss of consciousness or convulsions within the past six months
- •? A history of acute stroke within the last three months
- •? Uncontrolled hypertension, diabetes, thyroid dysfunction, or kidney failure
- •? Severe hearing or vision impairment that makes functional evaluation impossible
- •Individuals who have taken anti-dementia drugs or brain metabolism enhancers in the past month
- •Those who have taken psychotropic drugs within the past month
- •Those who have taken any drug or health functional food affecting cognitive function, or foods similar to the test material within the past month
- •Those who have participated in other clinical trials (including human trials) within the past month
- •Those with hypersensitivity to the ingredients in the investigational products or a history of severe allergic reactions
- •Individuals whom the principal investigator deems unsuitable for participation due to other reasons
研究组 & 干预措施
Others(Health Functional Food) : At Visit 1, participants who provide written informed consent will be assessed for eligibility according to the inclusion and exclusion criteria. At Visit 2, eligible participants will be randomized according to the order of enrollment to either the test food group (containing Policosanol-Sugarcane Wax Alcohols) or the placebo group and will consume one tablet of the assigned study product once daily for 12 weeks.
干预措施: Others(Health Functional Food) : At Visit 1, participants who provide written informed consent will be assessed for eligibility according to the inclusion and exclusion criteria. At Visit 2, eligible participants will be randomized according to the order of enrollment to either the test food group (containing Policosanol-Sugarcane Wax Alcohols) or the placebo group and will consume one tablet of the assigned study product once daily for 12 weeks.
研究者
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