None listed
Conditions
Interventions
Intervention1: Focus Elixir: Consume a single serving of one full bottle (70 ml) of Focus Elixir Drink once daily on an empty stomach ensuring a
minimum of 2 hours since the last meal
Control Interve
Sponsors
Weather Woods Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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
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 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.
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 attention using Attention Control Scale (ATTC/ACS-20) score 3. Assessment of changes in work productivity & performance based on Individual Work Performance Questionnaire (IWPQ) score 4. Changes in the fatigue severity scale (FSS) score 5. Changes in STAI (State-Trait Anxiety Inventory) score 6. Changes in the Epworth Sleepiness Scale for daytime sleepinessTimepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile 2. Treatment compliance and tolerability of investigational productTimepoint: 1. At baseline, day 7 and day 14. 2. At day 7 and day 14. | — |
Countries
India
Contacts
Public ContactYash Shukla
f2f food & beverages
Outcome results
None listed