KCT0000162已完成未知
Effects of fermented Korean red ginseng powder on the mild cognitive impairment for the efficacy and safety; a 12-week, multi-center, randomized, double-blind, placebo-controlled clinical trial
Well-Being LS0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- 55(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1. Physically healthy men and women aged between 55 and 85 years old who complain of memory loss and demonstrate a decrease of 1.0 SD or more on CERAD-K (Consortium to Establish a Registry for Alzheimer's Disease-Korean version)
- •2. People who are able to read and sign an informed consent before participating in the study
排除标准
- •1.People who are being hospitalized or within 3 months after hospital discharge for any types of malignant tumors, severe cardiovascular diseases (stroke, hemorrhage, etc), and sever heart diseases (angina, myocardial infarction, heart failure, arrhythmias requiring treatments). However, people who have a history of cardiovascular diseases but are clinically stable can participate in the study.
- •2.People who are currently suffering from schizophrenia or have a history of schizophrenia
- •3.People who have major depressive disorders categorized by DSM-IV
- •4.People who have poor cognitive function and have Alzheimer’s disease, Parkinson’s disease, or stroke. (The diagnosis of Alzheimer’s disease is based on DSM-IV)
- •5.People who have taken medications for Alzheimer’s disease or other cognitive function problems within 4 weeks prior to the first visit of the study. The examples of the medications are Antipsycotics, Neurodegenerative Disease Drugs, Nootropics & Neurotonics, and tricyclic antidepressant.
- •6.People with a daily intake of more than 400 IU vitamin E
- •7.People who have received estrogen replacement therapy within the first two months prior to the first visit of the study
- •8.People who have taken ginseng or red ginseng supplements for the purposes of improving cognitive function within the first two weeks prior to the first visit of the study
- •9.People with alcohol abuse or alcohol dependence
- •10.People with uncontrolled hypertension (170/100 mmHg or higher)
- •11.People with uncontrolled diabetes/blood sugar (fasting glucose of 180 mg/dl or higher)
- •12.People who have experienced side effects from taking ginseng or red ginseng products in the past
- •13.People with thyroid disease (TSH of 0.1 uU/ml or less, or TSH of 10 uU/ml or higher)
- •14.People with renal dysfunction whose creatinine level is more than twice the upper limit of normal range
- •15.People with dyshepatia or liver failure whose AST(GOT) or ALT(GPT) level is more than twice the upper limit of normal range
- •16.People who are pregnant or lactating women (for women who have a possibility of being pregnant, urine HCG test must be performed prior to the participation of the study)
- •17.People with any other health concerns
研究者
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