A Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults

Sponsor

Vedic Lifesciences Pvt. Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05821049

Collaborator

(none)

150

Enrollment

Locations

Arms

6.3

Anticipated Duration (Months)

37.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Other: UPI65 (Low Dose) Other: UP165 (High Dose) Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, double blind, placebo controlled, parallel groupA randomized, double blind, placebo controlled, parallel group

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Envelope Blinding Chits

Primary Purpose:

Other

Official Title:

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults

Anticipated Study Start Date :

Apr 25, 2023

Anticipated Primary Completion Date :

Aug 20, 2023

Anticipated Study Completion Date :

Nov 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: UPI65 (Low Dose) One capsule to be taken 60 ± 10 mins before bed	Other: UPI65 (Low Dose) Red colored Capsules
Active Comparator: UPI65 (High Dose) One capsule to be taken 60 ± 10 mins before bed	Other: UP165 (High Dose) Red colored Capsules
Placebo Comparator: Placebo One capsule to be taken 60 ± 10 mins before bed	Other: Placebo Red colored Capsules

Arm

Intervention/Treatment

Active Comparator: UPI65 (Low Dose)

One capsule to be taken 60 ± 10 mins before bed

Other: UPI65 (Low Dose)

Red colored Capsules

Active Comparator: UPI65 (High Dose)

One capsule to be taken 60 ± 10 mins before bed

Other: UP165 (High Dose)

Red colored Capsules

Placebo Comparator: Placebo

One capsule to be taken 60 ± 10 mins before bed

Other: Placebo

Red colored Capsules

Outcome Measures

Primary Outcome Measures

To assess the efficacy of the Investigational Product (IP) from baseline on [throughout the study period (approximately 28 days)]
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.
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 28]
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 21]
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 14]
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 7]
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 28]
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 21]
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 14]
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 7]
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 28]
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 21]
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 14]
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on [Day 7]
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female subjects ≥20 and ≤ 60 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form(IPAQ - SF)
Volunteers with body mass index between 18.5 and 29.9 kg/m2. Fairly bad or very bad subjective sleep quality with a score of 2 or 3 assessed as per PSQI Q9.
Willing to maintain current dietary pattern, activity level, and stable bodyweight for the duration of the study, and refrain from any drastic lifestyle changes.
Unable to fall asleep or unable to stay asleep (2 or more waking episodes during sleep at least twice a week but not more than four times)
Agrees to maintain current sleep schedule throughout the study
Agrees to stay in the current time zone for the duration of the study
Subjects ready to give voluntary, written, informed consent to participate in the study.
Willing to complete all study procedures including study-related questionnaires and comply with study requirements.

Exclusion Criteria:

Subjects diagnosed with sleep disorders secondary to another health problem.
Consumption of hypnotic drugs (<3 months before inclusion).
Subjects with a history of caffeine consumption post 6:00 pm.
Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
Recent history of physical, emotional, social trauma within last three months.
Participants who are not medication (which are likely to impact sleep quality or pattern) free for at least 4 weeks apart from contraceptive pills
Subjects who consume pain-relieving medications more than once per week.
Individuals who have night terrors regularly
Individuals who regularly sleepwalk
Individuals who work at night shifts.
Individuals who have regular bad dreams
Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, any illicit drugs
Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (<3 months before inclusion),
Recent (<3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and/or dietary supplement),
Students having regular class and assignments
Subjects addicted to digital media who exhibit at least five of the following symptoms currently:

Preoccupation with the digital media use j) Withdrawal symptoms that occur when digital media use is not possible k) Build-up of a tolerance that requires increasing amounts of digital media use to satisfy cravings l) Unsuccessful attempts to stop or limit digital media use m) Replacement of previously pleasurable activities with digital media use n) Unwillingness to stop digital media use despite its negative consequences o) Being deceptive about digital media use p) Using digital media use as a coping mechanism

Addiction or history of substance abuse,
Consumption of more than 3 glasses of alcohol per day,
Pregnant or lactating woman,
Lifestyle habits which would modify the wake-sleep rhythm, or which was expected to be modified during the study period (e.g., night work), and finally,
Known allergy to the IP.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aman Hospital and Research Center	Vadodara	Gujarat	India	390021
2	Shree Ashirwad Hospital	Dombivli	Maharashtra	India	421201
3	HMN Hospital	Mulund	Maharashtra	India	400080
4	Sai Cititcare	Ulhasnagar	Maharashtra	India	421004

Sponsors and Collaborators

Vedic Lifesciences Pvt. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vedic Lifesciences Pvt. Ltd.

ClinicalTrials.gov Identifier:

NCT05821049

Other Study ID Numbers:

UI/220902/UP/SQMS

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vedic Lifesciences Pvt. Ltd.

Sleep Quality

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Apr 27, 2023