Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
A Clinical Study of De-Stress Chill Gummies in Reducing Stress
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Parallel Arm Clinical Trial of De-Stress Chill Gummies in Reducing Stress and Anxiety and Improving Mood in Adults
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 on clinical validation of efficacy of nutraceutical product in reduction of stressanxiety and improving mood in adults Adults experiencing chronic stress and anxiety often suffer from a reduced quality of life marked by symptoms such as irritability fatigue and difficulty concentrating By integrating these gummies into their daily routine many report noticeable improvements in their emotional and mental state These enhancements can manifest as increased energy levels better sleep quality and a more balanced mood which collectively contribute to a more positive outlook on life
Detailed Description:
This is a randomized double-blind parallel-arm comparative multicenter placebo-controlled clinical trial of De-Stress and Chill Gummies in reducing stress and anxiety and improving mood in adults
In this study more than 72 participants will be enrolled and randomized into one of the following groups to achieve at least 72 completers at least 24 participants in each group Group A De-Stress and Chill Gummies-U001 Group B De-Stress and Chill Gummies-I001 and Group C Placebo Gummies-001 in a 111 ratio The study duration is 68 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed at screening
Assessment of changes in perceived stress scale PSS score LDH and creatine kinase levels body weight and BMI mental chatter score using 5-point scale Hamilton Anxiety Rating Scale HAM-A score COPE Questionnaire a Positive Subscale b Denial Subscale score STAI State-Trait Anxiety Inventory score visual analogue scale score- for evaluation of fatigue nausea palpitation breathlessness will be done at screening day 30 and day 60 Assessment of changes in serum cortisol levels will be done at screening day 15 and day 60 Assessment of changes in serotonin levels will be done at screening day 30 and day 45 Assessment of changes in Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be done at screening day 15 day 30 and day 60 Assessment of modified sleep regularity and medication withdrawal questionnaire MSRMWQ score after stopping treatment for 1 week day 68
Assessment of changes in vital sign parameters will be done at baseline Day 15 Day 30 Day 45 and Day 60 Assessment of changes in complete blood count liver function test and kidney function test at screening and Day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs will be assessed at baseline Day 15 Day 30 Day 45 and Day 60 Treatment compliance and tolerability will be assessed at Day 30 and Day 60
In this study more than 72 participants will be enrolled and randomized into one of the following groups to achieve at least 72 completers at least 24 participants in each group Group A De-Stress and Chill Gummies-U001 Group B De-Stress and Chill Gummies-I001 and Group C Placebo Gummies-001 in a 111 ratio The study duration is 68 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed at screening
Assessment of changes in perceived stress scale PSS score LDH and creatine kinase levels body weight and BMI mental chatter score using 5-point scale Hamilton Anxiety Rating Scale HAM-A score COPE Questionnaire a Positive Subscale b Denial Subscale score STAI State-Trait Anxiety Inventory score visual analogue scale score- for evaluation of fatigue nausea palpitation breathlessness will be done at screening day 30 and day 60 Assessment of changes in serum cortisol levels will be done at screening day 15 and day 60 Assessment of changes in serotonin levels will be done at screening day 30 and day 45 Assessment of changes in Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be done at screening day 15 day 30 and day 60 Assessment of modified sleep regularity and medication withdrawal questionnaire MSRMWQ score after stopping treatment for 1 week day 68
Assessment of changes in vital sign parameters will be done at baseline Day 15 Day 30 Day 45 and Day 60 Assessment of changes in complete blood count liver function test and kidney function test at screening and Day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs will be assessed at baseline Day 15 Day 30 Day 45 and Day 60 Treatment compliance and tolerability will be assessed at Day 30 and 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