DRKS00000423已完成1 期
Effects of Ginkgo biloba extract (EGb 761®) on cognitive control functions, mental activity of the prefrontal cortex and stress reactivity in adult healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy male and female volunteers = 50 and = 65 years of age
- •2. Written informed consent
- •3. Normal routine laboratory values of hematology and clinical chemistry
- •4. Average or slightly below average cognitive performance in psychometric testing
- •5. Female volunteers with childbearing potential must use effective means of contraception
- •6. Willingness and ability to comply with all protocol-specified procedures
排除标准
- •1. Depression that required any antidepressive drug treatment within the last 12 months
- •before study treatment and/or BDI-II score of = 18
- •2. Psychotherapeutic or psychiatric treatment within the last 12 months before study
- •3. Diabetes mellitus or other known other endocrine diseases (exception: adaequately
- •treated thyroid hypo- or hyperfunction)
- •4. Cerebrovascular diseases including stroke, Alzheimer’s disease or other dementia, other
- •neurological diseases such as multiple sclerosis, seizure disorders, cardiovascular disease or history of myocardial infarction, renal insufficiency or other chronic diseases
- •5. Any previous or concurrent malignancy or any cancer unless curatively treated > 3 years
- •prior to study entry except cervical carcinoma in situ or adequately treated basal cell
- •6. Hemorrhagic diathesis
- •7. Planned surgical intervention or hospital admission within the next six months
- •8. Any condition, including the presence of clinically relevant laboratory or ECG
- •abnormalities or abnormalities at physical examination, which places the subject at
- •unacceptable risk if he/she were to participate in the study or confounds the ability to
- •interpret data from the study
- •9. Any serious medical condition, laboratory abnormality, or psychiatric illness that would
- •prevent the subject from giving informed consent
- •10. Intake of any preparation containing Ginkgo biloba within the last eight weeks
- •11. Concomitant medication affecting central nervous system
- •12. Cardiac pacemaker, cochlea implants or other implanted metal devices, residual metal
- •13. Marked claustrophobia
- •14. Smokers with a consumption of > 15 cigarettes per day
- •15. Hypersensitivity against Ginkgo biloba dry extract or any of the other constituents of
- •study medication (including lactose intolerance)
- •16. Any antithrombotic treatment within the last four weeks or still ongoing
- •17. Pregnant or lactating women
- •18. Participation in a further clinical trial with experimental drug or experimental therapy at
- •the same time or within the past 4 weeks
- •19. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g.
- •partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease,
- •symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •20. Insufficient German language skills
研究者
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