Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571331
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
A Clinical Trial of De-Stress Snooze Gummies in Reducing Stress and Insomnia Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Parallel Arm Clinical Trial of De-Stress and Snooze Gummies in Reducing Stress Insomnia Disorder Associated Symptoms and Overall Quality of Life
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 management of sleep disorder Improved sleep quality contributes significantly to cognitive function With a good nights sleep individuals often find themselves more alert focused and better equipped to handle complex tasks and problem-solving scenarios This can enhance productivity at work as well as improve the ability to engage in meaningful conversations and activities Memory consolidation which occurs during sleep is also optimized leading to better retention of information and a sharper mind
Detailed Description:
A randomized double-blind placebo-controlled clinical trial of De-Stress and Snooze Gummies in reducing stress insomnia disorder associated symptoms and overall quality of life
More than 60 Participants will be randomized to either one of the following groups
Group A Group B and Group C will involve 20 participants each group 111 ratio will be advised to take Destress and snooze gummies - U001 Destress and snooze gummies - I001 and Placebo gummies-002 respectively two gummies in sequence daily 30 minutes before bed for 60 days The treatment duration is of 60 days and the study duration is of 68 days The efficacy of the investigational product will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening
Assessments of changes in stress through PSS scores serum serotonin restorative sleep by RSQ-W score under eye dark circles based on bespoke scale and headache by VAS score will be conducted on screening day 30 and day 60
Changes in serum cortisol levels will be evaluated at screening day 15 and day 60 Additionally participants sleep diaries will be assessed to determine the changes in total sleep time sleep latency number of awakenings wake time after sleep onset sleep efficiency total sleep timetime in bed 100 and levels of alertness and drowsiness and actigraphy assessment using Fitbit device to evaluate sleep efficiency deep sleep light sleep and REM sleep duration as well as overall sleep scores which will be tracked for 10 individuals 3-4 subjects per group at baseline day 30 and day 60
Changes in the Functional Outcomes of Sleep Questionnaire FOSQ-10 and the abbreviated Profile of Mood States POMS-A score to investigate mood changes and safety through complete blood count liver function test and kidney function test will be assessed at screening and day 60
Changes in the modified sleep regularity and medication withdrawal questionnaire MSRMWQ score will be assessed after ceasing treatment for one week day 68 telephonically
Treatment compliance and tolerability will be assessed at day 30 and day 60 and safety of the investigational treatment in terms of adverse events will be assessed at baseline day 15 day 45 and day 60 Changes in vital sign parameters will be assessed at screening baseline day 15 day 30 day 45 and day 60
More than 60 Participants will be randomized to either one of the following groups
Group A Group B and Group C will involve 20 participants each group 111 ratio will be advised to take Destress and snooze gummies - U001 Destress and snooze gummies - I001 and Placebo gummies-002 respectively two gummies in sequence daily 30 minutes before bed for 60 days The treatment duration is of 60 days and the study duration is of 68 days The efficacy of the investigational product will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening
Assessments of changes in stress through PSS scores serum serotonin restorative sleep by RSQ-W score under eye dark circles based on bespoke scale and headache by VAS score will be conducted on screening day 30 and day 60
Changes in serum cortisol levels will be evaluated at screening day 15 and day 60 Additionally participants sleep diaries will be assessed to determine the changes in total sleep time sleep latency number of awakenings wake time after sleep onset sleep efficiency total sleep timetime in bed 100 and levels of alertness and drowsiness and actigraphy assessment using Fitbit device to evaluate sleep efficiency deep sleep light sleep and REM sleep duration as well as overall sleep scores which will be tracked for 10 individuals 3-4 subjects per group at baseline day 30 and day 60
Changes in the Functional Outcomes of Sleep Questionnaire FOSQ-10 and the abbreviated Profile of Mood States POMS-A score to investigate mood changes and safety through complete blood count liver function test and kidney function test will be assessed at screening and day 60
Changes in the modified sleep regularity and medication withdrawal questionnaire MSRMWQ score will be assessed after ceasing treatment for one week day 68 telephonically
Treatment compliance and tolerability will be assessed at day 30 and day 60 and safety of the investigational treatment in terms of adverse events will be assessed at baseline day 15 day 45 and day 60 Changes in vital sign parameters will be assessed at screening baseline day 15 day 30 day 45 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