ACTRN12610000849099已完成3 期
A study of the acute cognitive and neurocognitive effects of Panax Quinquefolius in healthy middle aged volunteers.
aturex0 个研究点目标入组 50 人开始时间: 2010年10月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Healthy non-smoking males and females aged between 40 and 60 years.
- •2. No history of anxiety, depression, psychiatric disorders confirmed using Depression Anxiety Stress Scale) or epilepsy
- •3. No history of / do not currently suffer from heart disease or high blood pressure or diabetes
- •4. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
- •5. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
- •6. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
- •7. Absence of pregnancy (confirmed using a pregnancy test)
- •8. Are willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- •9. Are willing to provide small finger prick blood samples throughout the testing phases
- •10. Are not photosensitive (a sensitivity to visual stimuli, such as flashing lights, bright lights, light presented to full visual field, or static or moving patterns of light and dark stripes)
- •11. Absence of cognitive decline and a score > 24 on the mini mental state examination and within normal ranges on CDR battery
- •12. Understand the rating scales and computer tests (as judged by the study coordinator)
- •13. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
- •14. Have a fasting blood glucose <6.1mmol/l
- •15. Systolic blood pressure withing the normal range (91-139mmHg) and diastolic blood pressure within the normal range (61-89mmHg)
排除标准
- •Smoker, hypersensitivity to investigational product, anxiety, depression, psychiatric disorder, epilepsy, heart disease, high blood pressure, diabetes, taking medications, health conditions that would effect food metabolism, pregnant/breast feeding, unable to commit to testing days, photo sensitive, not willing to provide finger prick blood samples, use of over the counter herbal supplements and dietary supplements 4 weeks prior to the study, history of head injury/stroke, alcoholism, clinically relevant abnormalities in medical history.
研究者
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