To study the effects of caffeine and a glucose-caffeine combination on psychomotor performance among students and staffs of Government Medical College and Research Institute in Bangalore.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in psychomotor performance after administration of:
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of caffeine and a glucose-caffeine combination on psychomotor performance among healthy students and staff of a medical college. Participants will be randomized into three groups—caffeine, glucose-caffeine, and placebo—and assessed using standardized tests including DLST, SLCT, Card Sorting, and the Purdue Pegboard Test. The primary outcome is the change in psychomotor performance scores at 30 and 45 minutes post-intervention compared to baseline. Secondary outcomes include changes in subjective alertness measured by Visual Analogue Scale (VAS) and variations in vital parameters such as blood pressure and pulse rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Students and staffs whose hematological and biochemical parameters are within normal limits.
- •Students and staffs age group between 18-40years.
排除标准
- •Smoker -Students and staffs on oral contraceptives.
- •Students and staffs with history of caffeine allergy.
- •Students and staffs with severe anxiety, cardiovascular diseases or symptomatic cardiac arrhythmias.
- •Students and staffs with peptic ulcer disease or gastroesophageal reflex disease.
- •Students and staffs who are pregnant.
- •Students and staffs with chronic diseases.
结局指标
主要结局
Change in psychomotor performance after administration of:
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
1)Caffeine alone
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
2)Glucose-caffeine combination
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
3)Placebo (water)
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
This will be assessed using:
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
1)DLST (Digit Letter Substitution Task)
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
2)SLCT (Six Letter Cancellation Test)
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
3)Card Sorting Test
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
4)Purdue Pegboard Test (PPT)
时间窗: Baseline (pre-administration) | 30 minutes post-administration | 45 minutes post-administration
次要结局
- Changes in VAS scores (alertness, calmness, drowsiness) and vital parameters (blood pressure, pulse rate) at 30 and 45 minutes post-intervention.
研究者
Dr Revathi
Shri Atal Bihari Vajpayee Medical College and Research Institute