A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of ITCs oral solid dose caffeine granules for the clinical evaluation of its efficacy as an instantaneous stimulant & overall energy and mood booster.
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC Limited
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from the baseline to the end of the treatment period in:
概览
简要总结
Caffeine is the most commonly consumed stimulant worldwide and caffeinated beverages, like coffee, have been consumed for centuries. Caffeine has been extensively studied and used to improve cognitive performance, mental alertness, and energy. Caffeine possesses performance enhancing benefits including physical endurance, reduction of fatigue, and enhancing mental alertness and concentration and therefore caffeine is consumed for a variety of reasons.
The current study is planned to assess the effectiveness of caffeine granules towards the management of mood and alertness in general healthy population. A total of 80 Eligible healthy subjects in the age group of 18-60 years of both genders will be randomized into 1:1 and will be assigned to either active caffeine or placebo group of 40 subjects each based on the protocol-defined randomization procedure. The effectiveness of the active caffeine granules will be assessed through psychometric and quality of life questionnaires. The clinical data will be processed for the statistical assessment to check the effectiveness of active caffeine granules over the placebo towards the mental alertness, mood and general well-being of the study participants. The total study duration is 15 days comprising of three clinical visits including two times blood testing at the baseline and at the end of the study. Physical examination and adverse event information will be assessed at each visit.
The effectiveness of the formulation for mood enhancing, anti-stress, alertness and over-all energetic are typically assessed in terms of the management of the parameters of mood profile and quality of life during a suggested period of 2 weeks study. This is the optimal treatment duration to demonstrate the objective of achieving the safety, efficacy and over-all acceptance of formulation for long term consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects between the age groups of 18–60 years 2.Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
排除标准
- •1.Subjects with the current history of smoking and/or alcohol consumption.
- •2.Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc.
- •3.Subjects with a known history of any malignant disease.
- •4.Subjects with known history of autoimmune disease and other systemic diseases related to immune system.
- •5.Subjects suffering with any severe infectious or communicable diseases like HIV & HBsAg. 6.Subjects with concomitant treatment with corticosteroids.
- •7.Subjects who participated in another clinical trial less than 3 months prior to this study.
- •8.Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period.
- •9.Subjects with the history of consumption of any recreational drugs.
- •11.Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic 12.Subjects with inability or unwillingness to abide by the requirements of the protocol.
- •13.Subjects who are incompetent to sign an Informed Consent Form.
结局指标
主要结局
Change from the baseline to the end of the treatment period in:
时间窗: 0 Day, 7th Day, 15th Day
o Profile of Mood States (POMS) Scale Score.
时间窗: 0 Day, 7th Day, 15th Day
次要结局
- Change from the baseline to the end of the treatment period in:
研究者
Dr Poorna Prasad S
Sri Venkateshwara Hospital