Arandomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Focus Elixir Drink in enhancing focus attention energy levels and anxiety management in adults
试验速览
- 阶段
- 2 期
- 状态
- 进行中（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 anxiety 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 focus, attention and anxiety management. 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 focus, attention, 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
- •1.Male and female participants aged 18-30 years (both inclusive);2.No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire (FAQ);3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form;4.Nosevere anxiety and depression on STAI and PHQ-9 scales;5.Able to complete the assessment questionnaires.
排除标准
- •1.Inability to perform any of the assessments required for endpoint analysis 2.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; 3.Have any other neurodegenerative diseases; 4.History of a seizure disorder; 5.Known hypersensitivity to investigational products 6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy 7.Sitting or resting systolic blood pressure more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg at Screening; 8.Participants with a history of substance abuse, drugs, heavy use of alcohol, or smoking within the last 5 years; 9.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; 10.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 11.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of 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. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
2. Assessment of changes in attention using Attention Control Scale (ATTC/ACS-20) score
时间窗: 1. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
3. Assessment of changes in work productivity & performance based on Individual Work Performance Questionnaire (IWPQ) score
时间窗: 1. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
4. Changes in the fatigue severity scale (FSS) score
时间窗: 1. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
5. Changes in STAI (State-Trait Anxiety Inventory) score
时间窗: 1. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
6. Changes in the Epworth Sleepiness Scale for daytime sleepiness
时间窗: 1. at Day 1 | 2. at Days 1,7 and 14 | 3. at Days 1,7 and 14 | 4. at screening ,day7 and day 14 | 5. at screening ,day7 and day 14 | 6. at screening ,day7 and day 14
次要结局
- 1. Adverse events profile(2. Treatment compliance and tolerability of investigational product)
研究者
Dr Yogesh Lad
Ayushri Multispeciality Hospital Pvt.Ltd