A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual working memory test
研究概览
简要总结
This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function
详细描述
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons who are at least 60 years of age at screening
- •Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- •Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
排除标准
- •Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- •Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
- •Patients with alcohol abuse or dependence within the last 3 months
- •Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- •Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng
- •Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
- •Patients who ingested ginseng and red ginseng extract's health functional food within 1 month before screening
- •Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- •Patients who participate in another human trial within 3 months
- •Those who show the following results in the Laboratory test
- •AST, ALT > 3 times upper limit of the normal range
- •Other significant laboratory test opinion
- •Patients who are deemed unsuitable for participating in the human trial due to other reasons
研究组 & 干预措施
Hydrolysed Red Ginseng Extract
Hydrolysed Red Ginseng extract for 1g/day
干预措施: Hydrolysed Red Ginseng Extract (Dietary Supplement)
Placebo
Hydrolysed Red Ginseng extract for 0g/day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Visual working memory test
时间窗: 12 weeks
Visual working memory test was measured in baseline and 12 week.
Visual learning test
时间窗: 12 weeks
Visual learning test was measured in baseline and 12 week.
MoCA-K; Korean Version of the Montreal Cognitive Assessment
时间窗: 12 weeks
Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
次要结局
- Verbal learning test(12 weeks)
- TAS(Total antioxidant status)(12 weeks)
- Auditory continuous performance test(12 weeks)
- BDI; Beck Depression Inventory(12 weeks)
- PSS; Perceived stress scale(12 weeks)
- BDNF; Brain-derived neurotrophic factor(12 weeks)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital