CTRI/2017/09/009826已完成不适用
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
- 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 Cantab® between active and placebo group
研究概览
简要总结
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
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Subjects between the ages of 18 and 50 years, providing written informed consent.
- •â€¢ All the potential study participant should have the recent complete clinical profile of biochemistry, renal function, liver function and hematological data within one year.
排除标准
- •Any one of the following • 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 within the last 12 months • Any characteristic that makes the investigator uncomfortable to include the subject in the study. • Pregnant, attempting to conceive, or lactating women.
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 Cantab® between active and placebo group
时间窗: 6 weeks
次要结局
- To measure change in Cohen Perceived Stress Scale in 6 weeks(6 weeks)
- To measure change in cortisol level from saliva in 6 weeks(6 weeks)
- To meaure change in The State-Trait Anxiety Inventory(STAI) in 6 weeks(6 weeks)
研究者
研究点 (1)
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