Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess a change in facilitative cognitive function from baseline in 6 weeks by comparing the results on cognitive tests measured by Cambridge Neuropsychological Test Automated Battery (Cantab®) between active and placebo group
研究概览
简要总结
Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.
详细描述
Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. Stress and an inability to perform at a required level of cognition can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Concealment of allocation and blinding of active versus placebo and blinded assessment
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 18 and 50 years, providing written informed consent.
排除标准
- •Subjects who meet the following criteria
- •Education level below 8th grade of schooling
- •Unable to read or understand English or having no working knowledge of English
- •Known history or neurological conditions that can affect cognition
- •Known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study.
- •A chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption
- •Any history or psychiatric disorders - currently on treatment or treated in within the last 12 months
- •Any characteristic that makes the investigator uncomfortable to include the subject in the study.
研究组 & 干预措施
Tulsi active
干预措施: Ocimum Sanctum (Drug)
Tulsi placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To assess a change in facilitative cognitive function from baseline in 6 weeks by comparing the results on cognitive tests measured by Cambridge Neuropsychological Test Automated Battery (Cantab®) between active and placebo group
时间窗: 6 weeks
The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a digital tool to measure the cognitive function.
次要结局
- To measure change in Generalized Anxiety Disorder 7-Item Scale in 6 weeks(6 weeks)
- To measure change in cortisol level from saliva in 6 weeks(6 weeks)