About this trial
The current study focuses in clinical validation of the efficacy of nutraceutical product in the 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to perform any of the assessments required for endpoint analysis
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
Have any other neurodegenerative diseases
History of a seizure disorder
Trial design
Parallel
Treatments tested in this trial
De-Stress and Focus capsule- U001
Other interventionTwo capsules in sequence daily after meal for 60 days.
De-Stress and Focus capsule - I001
Other interventionTwo capsules in sequence daily after meal for 60 days.
Placebo capsules 001
Other interventionTwo capsules in sequence daily after meal for 60 days.
Treatment groups
Trial outcomes
Primary outcomes
Perceived Stress Scale
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) MoCA was a questionnaire performed preoperative then post-operative. The MoCA used in this study was developed by Professor Nasreddine in 2004 and is used for the rapid screening assessment of mild cognitive impairment. The cognitive areas assessed by MoCA included attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation. The scale had a total score of 30 points. ≥26 points were considered as having no cognitive impairment .
Rey Complex Figure Test (RCFT)
The RCFT 'copy' is a validated, instrument assessing visuo-constructive abilities. The RCFT 'copy' requires the subject to observe and replicate an image. The score is scored as 0, 0.5, 1 or 2 for each of the 18 factors. Point 2 is when the shape and position of the element is accurately drawn, point 1 is when one of the shape or position is correct. Point 0.5 is when both the shape and position are incorrect, but the examinee can determine what the subject was trying to draw, and point 0 is the case when the shape and position difference are both inadequate, and when the element is not drawn. The total score is the sum of the scores scored for each of the 18 elements; It is possible scores range from 0 to 36(Higher numbers indicate better).
Change in Trail Making Test (TMT) Between Baseline and End of Treatment
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Secondary outcomes
Safety of participant assessed using adverse events.
It is measure in terms of No. of events.
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Locations
Sponsors and contacts
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