An open-label, single centre, pilot clinical study to evaluate the effect of CurQfen on brain function in Middle aged to Elderly population by Quantitative EEG analysis and cognitive assessment tests.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- - Comparative changes EEG in basline and after administration of CurQfen
研究概览
简要总结
This is a Single Centre Open Label Clinical study. The main purpose of the study is to prove the efficacy of CurQfen on Brain Function.
Helathy subjects are enrolled to participate in the study. Informed consent is obtained before undertaking any study related procedures. Subjects with a MMSE score greater or equal to 25 are enrolled in the study. The subjects visited their designated study site on following 4 different occasions:
Screening
Baseline : Day 0
Visit 3 : Day 15
Visist 4 : Day 30
Efficay and safety is established by comparing the end of study values with baseline values..
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 35-65 Years ( Both Inclusive) 2)Male and Female Subjects 3)Subjects in general good health.
- •Subjects with a MMSE score between 25 – 30.
排除标准
- •EXCLUSION CRITERIA 1)Subjects with a education qualification less than higher secondary level 2)Subjects who are not familiar with computer/internet use.
- •Subject with dementia/related memory loss illness 4)Subjects diagnosed with learning difficulty such as dyslexia or dyspraxia 5)Suffering from any form of clinically diagnosed disease, including: oMajor mental illness (current or previous episode with hospitalization) oChronic fatigue syndrome oLiver disease oDiabetes mellitus oHeart disease or myocardial infarction ounderwent brain surgery owho have a central nervous system illness oneurological lesion 6)Subjects with a known allergy to herbal products 7)Subjects with abnormal biochemical or haematological values 8)Subjects with abnormal blood pressure 9)Pregnant or Lactating Women 10)Any condition that in Opinion of the Investigator, does not justify the Subjects’ participation in the study.
结局指标
主要结局
- Comparative changes EEG in basline and after administration of CurQfen
时间窗: Day 0, Day 15, Day 30
-Comparative changes in cognitive assessment test scores
时间窗: Day 0, Day 15, Day 30
次要结局
- - Change in Brain Derived Neurotrophic factor (BDNF)(- safety of CurQfen)