Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568965
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Clinical Study of De-Stress Happy Gut Powder for Stress and Indigestion in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Arm Clinical Trial of De-Stress and Happy Gut Powder in Relieving Stress and Functional Dyspepsia Symptoms 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 relieving stress and functional dyspepsia symptoms in adults for gut health The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being Improved digestive health leads to better nutrient absorption which is essential for energy levels and immune function Reduced stress levels contribute to better sleep quality cognitive function and emotional stability
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-arm clinical trial of De-Stress Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults
In this study more than 81 participants will be enrolled in a 111 ratio into three groups Group A De-stress Happy Gut Powder-U001 Group B De-stress Happy Gut Powder-I001 and Group C Placebo Powder 001 Each participant will take one sachet daily 30 minutes before breakfast for 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale PSS score Nepean Dyspepsia Index NDI changes in serum cortisol levels changes in the COPE Questionnaire a Positive Subscale b Denial Subscale score assessing gut health using a Gastrointestinal Symptom Rating Scale GSRS score will be assessed at screening day 30 and day 60
Changes in the State-Trait Anxiety Inventory STAI score changes in the Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be assessed at screening and day 60
Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia Upper abdominal fullness Pain Belching Bloating Early satiety Nausea Vomiting Regurgitation Heartburn Loss of appetite cravings for junk food will be assessed at screening day 15 30 and day 60
Changes in gut microbiota at screening and day 60 and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flareheartburn will be assessed at baseline day 15 30 and day 60
Treatment compliance tolerability of investigational products will be assessed at day 30 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 and day 60
Assessment of changes in vital sign parameters will be done from screening to end of the study Day 60
In this study more than 81 participants will be enrolled in a 111 ratio into three groups Group A De-stress Happy Gut Powder-U001 Group B De-stress Happy Gut Powder-I001 and Group C Placebo Powder 001 Each participant will take one sachet daily 30 minutes before breakfast for 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed on screening The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale PSS score Nepean Dyspepsia Index NDI changes in serum cortisol levels changes in the COPE Questionnaire a Positive Subscale b Denial Subscale score assessing gut health using a Gastrointestinal Symptom Rating Scale GSRS score will be assessed at screening day 30 and day 60
Changes in the State-Trait Anxiety Inventory STAI score changes in the Profile of Mood State POMS questionnaire score a Total Mood Disturbance b Depression will be assessed at screening and day 60
Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia Upper abdominal fullness Pain Belching Bloating Early satiety Nausea Vomiting Regurgitation Heartburn Loss of appetite cravings for junk food will be assessed at screening day 15 30 and day 60
Changes in gut microbiota at screening and day 60 and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flareheartburn will be assessed at baseline day 15 30 and day 60
Treatment compliance tolerability of investigational products will be assessed at day 30 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 and day 60
Assessment of changes in vital sign parameters will be done from screening to 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