A randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcomes are as follows-
研究概览
简要总结
The current study focuses in clinical validation of efficacy of nutraceutical product in management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement. Improved mental focus can lead to increased productivity and efficiency in both personal and professional settings. Individuals who struggle with attention deficits or cognitive fog may find that these supplements help them maintain a sharper and more consistent level of mental clarity. This can translate to better performance at work, as well as improved ability to manage daily tasks and responsibilities.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged 18-50 years both inclusive
- •Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- •Scoring 18-26 on the Montreal Cognitive Assessment MoCA
- •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 GAD and PHQ-9 scales
- •Able to complete the cognitive assessment tests.
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 Alzheimer’s Disease, acquired immunodeficiency syndrome AIDS, Creutzfeldt-Jakob disease, 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, and/or smoking within last 5 years 9.Participants currently using medications and or 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 patient or preclude the successful completion of the study.
结局指标
主要结局
Primary outcomes are as follows-
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
1.Changes in perceived stress scale (PSS) score, Montreal Cognitive Assessment (MoCA) scale score, Rey Complex Figure Test (RCFT), Trail Making Test (TMT) score, digit span memory test, fatigue severity scale (FSS) score, mental chatter 5-point scale, Epworth Sleepiness Scale for daytime sleepiness, energy levels by using energy audit diary.
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
2.Assessment of alertness, orientation, and executive control functioning and executive/arousal vigilance will be assessed using ANTI-Vea-UGR computerized test(5 participants from each group i.e, total 15 participants)
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
3. Assessment of changes in the adult ADHD Self-Report Scale (ASRS) score
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
4.COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression)
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
5.Serum cortisol levels
时间窗: 1.Screening, baseline, day 15, day 30, day 60 | 2.0 hr, 1hr, 4 hr and 8 hr after dosing on day 1 and day 60 | 3.Screening, baseline, day 15, day 30, day 60 | 4.Screening and day 60 | 5.screening, day 15 and day 60
次要结局
- Secondary outcomes are as follows- 1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters 2.Assessment of changes in complete blood count, liver function test and kidney function test(1.Baseline, day 15, day 30, day 60)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital