Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569849
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
A Clinical Trial of De-stress and Focus Capsule in the Management of Stress
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This is 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
In this study more than 60 participants will be enrolled and randomized to either one of the following groups Group A De-Stress and Focus Capsules-U001 Group B De-Stress and Focus Capsules-I001 Group C Placebo Capsules 001 in 111 ratio 20 patients in each group The study duration is 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening
Assessment of 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 - forward and backward for attention and working memory assessment most extended sequence fatigue severity scale FSS score mental chatter 5-point scale Epworth Sleepiness Scale for daytime sleepiness energy levels by using energy audit diary and adult ADHD Self-Report Scale ASRS score will be done at screening day 30 and day 60
Assessment of serum cortisol levels will be done at screening day 15 and day 60
Assessment of COPE Questionnaire a Positive Subscale b Denial Subscale score STAI State-Trait Anxiety Inventory score and Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be done at screening and day 60
Assessment of alertness orientation executive control functioning and executivearousal vigilance will be assessed using ANTI-Vea-UGR computerized test will be done at 0 hr 1hr 4 hr and 8 hr after dosing on day 1 and day 60 5 participants from each group ie total 15 participants
Changes in vital sign parameters will be assessed from screening to the end of the study Day 60 Assessment of changes in complete blood count liver function test and kidney function test will be done at screening and end of the study Day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs from screening to end of the study Day 60 Treatment compliance and tolerability will be assessed from baseline to the end of the study Day 60
In this study more than 60 participants will be enrolled and randomized to either one of the following groups Group A De-Stress and Focus Capsules-U001 Group B De-Stress and Focus Capsules-I001 Group C Placebo Capsules 001 in 111 ratio 20 patients in each group The study duration is 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening
Assessment of 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 - forward and backward for attention and working memory assessment most extended sequence fatigue severity scale FSS score mental chatter 5-point scale Epworth Sleepiness Scale for daytime sleepiness energy levels by using energy audit diary and adult ADHD Self-Report Scale ASRS score will be done at screening day 30 and day 60
Assessment of serum cortisol levels will be done at screening day 15 and day 60
Assessment of COPE Questionnaire a Positive Subscale b Denial Subscale score STAI State-Trait Anxiety Inventory score and Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be done at screening and day 60
Assessment of alertness orientation executive control functioning and executivearousal vigilance will be assessed using ANTI-Vea-UGR computerized test will be done at 0 hr 1hr 4 hr and 8 hr after dosing on day 1 and day 60 5 participants from each group ie total 15 participants
Changes in vital sign parameters will be assessed from screening to the end of the study Day 60 Assessment of changes in complete blood count liver function test and kidney function test will be done at screening and end of the study Day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs from screening to end of the study Day 60 Treatment compliance and tolerability will be assessed from baseline to the end of the study Day 60
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None