A randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Focus Elixir Drink in enhancing focus, cognitive function, energy levels, and mood regulation in adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. The assessment of acute effects of Focus Elixir Drink evaluated by changes in sustained focus, memory, and freshness questionnaire score recorded pre dose (0 minutes), and 5 hours post dose.
研究概览
简要总结
The rising prevalence of cognitive fatigue, low energy, and mood fluctuations in adults highlights an urgent need for effective, safe interventions. these challenges significantly impair daily functioning and quality of life. Traditional pharmacological treatments, while sometimes effective, often come with side effects such as anxiety and dependency.
Natural dietary supplements are emerging as promising alternatives, particularly those with ingredients like L-carnitine, choline, ginseng, bacopa monnieri, L-tyrosine, L-citrulline malate, and green tea extract. These compounds have demonstrated benefits in enhancing cognitive performance and mood regulation. However, comprehensive studies assessing the synergistic effects of these ingredients in a single formulation are lacking.
Focus Elixir Drink is designed to fill this gap by combining these powerful ingredients into a scientifically formulated beverage aimed at boosting cognitive function, energy levels, and emotional well-being. This study will rigorously evaluate the efficacy and safety of Focus Elixir Drink, providing valuable insights into its potential as a safe, effective alternative to conventional treatments for cognitive enhancement and mental wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged 18 to 30 years (both inclusive)
- •No or minimal impairment in activities of daily living scoring less than 9 on the Functional Activities Questionnaire (FAQ).
- •Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
- •No severe anxiety and depression on the GAD 7 and PHQ 9 scales.
- •Able to complete the cognitive assessment tests.
排除标准
- •Inability to perform any of the assessments required for endpoint analysis.
- •Shows signs of Dementia, such as caused by Alzheimers Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH), cardiac disease or endocrine disease.
- •Have any other neurodegenerative diseases.
- •History of a seizure disorder.
- •Known hypersensitivity to investigational products.
- •Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy.
- •Sitting or resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening.
- •Participants with a history of substance abuse, drugs, heavy use of alcohol, or smoking within the last 5 years.
- •Participants currently using medications and supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement.
- •Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study.
结局指标
主要结局
1. The assessment of acute effects of Focus Elixir Drink evaluated by changes in sustained focus, memory, and freshness questionnaire score recorded pre dose (0 minutes), and 5 hours post dose.
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
2. Assessment of changes in response time (alertness, orientation, executive control) and executive surveillance hits will be assessed using the ANTI Vea UGR computerized test.
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
3. Changes in the fatigue severity scale (FSS) score.
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
4. Changes in Profile of Mood State (POMS) questionnaire score (A. Total Mood Disturbance B. Depression).
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
5. Changes in the Epworth Sleepiness Scale for daytime sleepiness.
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
6. Changes in energy levels by using an energy audit diary.
时间窗: 1. Day 1. | 2. At Days 1 and 14. | 3. At screening, day 7 and day 14. | 4. At screening and day 14. | 5. At screening, day 7 and day 14. | 6. At baseline, day 7 and day 14.
次要结局
- 1. Adverse events profile.(2. Treatment compliance and tolerability of investigational product.)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre