A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
175
Red colored Capsules
Red colored Capsules
Red colored Capsules
V.S. General Hospital
Ahmedabad, Gujarat, India
Aman Hospital and Research Center
Vadodara, Gujarat, India
Poojan Multispeciality Hospital
Ahmedabad, Maharashtra, India
Shree Ashirwad Hospital
Dombivali, Maharashtra, India
To assess the efficacy of the Investigational Product (IP) from baseline on
Sleep statistics (sleep quality thoughout the study) by using the watch known as Garmin vivosmart 4 Tracker. This watch will be used to measure the deep sleep, REM sleep and wake-up time in hours.
Time frame: throughout the study period (approximately 28 days)
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 7
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time frame: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time frame: Day 21
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Sai Cititcare
Ulhasnagar, Maharashtra, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, India
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time frame: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time frame: Day 7
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time frame: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time frame: Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time frame: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time frame: Day 7