None listed
Conditions
Interventions
Intervention1: MA2/24- sachet: One sachet in 200ml water once in a day for 28 days
Intervention2: MA2/24 + Caffeine: One sachet in 200ml water once in a day for 28 days
Intervention3: Caffeine: One s
Sponsors
Akay Natural Ingredients Private Limited,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects who are working-class professionals 2.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 3.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period. 4.Subjects willing to refrain from taking any medications or preparations to improve fatigue (herbal, dietary supplements, homeopathic preparations, etc.) during the study. 5.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days. 6.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days. 7.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days. 8.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 9.Having basic computer literacy and exposure to computerized tests. 10.Must be willing and able to give informed consent and comply with the study procedures. 11.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
Exclusion criteria
Exclusion criteria: 1.Consumption of any cognition, energy and mood improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines. 2.Having hypersensitivity or history of allergy to the study product. 3.Subjects with moderate to severe fatigue or having chronic fatigue syndrome. 4.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator. 6.Subjects with a psychiatric diagnosis other than anxiety or depression. 7.Subjects with sleep disturbances and or are taking sleep aid medication. 8.Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening. 9.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications. 10.Subjects with a history of drug and or alcohol abuse at the time of enrolment. 11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 12.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit. 13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. 14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of BF-24 arms compared to placebo in Cognitive PerformanceTimepoint: Day 1, Day 3, Day 7, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of BF-24 arms on Blood BiomarkersTimepoint: Day 1, Day 3, Day 7, Day 14, Day 28;Overall SafetyTimepoint: Day 1, Day 3, Day 7, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactJestin VThomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed