None listed
Conditions
Interventions
Intervention1: Focus Elixir: Consume a single serving of one full bottle (60 ml) of Focus Elixir Drink once daily on an empty stomach, ensuring a minimum of 2 hours since the last meal for 14 days.
C
Sponsors
Weather Woods Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18 to 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. No severe anxiety and depression on the GAD 7 and PHQ 9 scales. 5. Able to complete the cognitive assessment tests.
Exclusion criteria
Exclusion criteria: 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 greater than 180 mm Hg or diastolic blood pressure greater 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. 3. Changes in the fatigue severity scale (FSS) score. 4. Changes in Profile of Mood State (POMS) questionnaire score (A. Total Mood Disturbance B. Depression). 5. Changes in the Epworth Sleepiness Scale for daytime sleepiness. 6. Changes in energy levels by using an energy audit diary.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile. 2. Treatment compliance and tolerability of investigational product.Timepoint: 1. At baseline, day 7 and day 14. 2. At day 7 and day 14. | — |
Countries
India
Contacts
Public ContactYash Shukla
f2f food and beverages
Outcome results
None listed