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

NCT05821049 | Completed

• 1 other identifier: UI/220902/UP/SQMS
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 6

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

Conditions

Sleep Disturbance

Keywords

Sleep Quality

Outcome Measures

Primary Outcomes (13)

• 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.

  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)

  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)

  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)

  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)

  Day 7

• To assess the efficacy of the Investigational Product (IP) from baseline on

  Mood using POMS-A (Profile of Moods States - Abbreviated version)

  Day 28

• To assess the efficacy of the Investigational Product (IP) from baseline on

  Mood using POMS-A (Profile of Moods States - Abbreviated version)

  Day 21

• To assess the efficacy of the Investigational Product (IP) from baseline on

  Mood using POMS-A (Profile of Moods States - Abbreviated version)

  Day 14

• To assess the efficacy of the Investigational Product (IP) from baseline on

  Mood using POMS-A (Profile of Moods States - Abbreviated version)

  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)

  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)

  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)

  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)

  Day 7

Study Arms (3)

UPI65 (Low Dose)

ACTIVE COMPARATOR

One capsule to be taken 60 ± 10 mins before bed

Other: UPI65 (Low Dose)

UPI65 (High Dose)

ACTIVE COMPARATOR

One capsule to be taken 60 ± 10 mins before bed

Other: UP165 (High Dose)

Placebo

PLACEBO COMPARATOR

One capsule to be taken 60 ± 10 mins before bed

Other: Placebo

Interventions

UPI65 (Low Dose) OTHER

Red colored Capsules

UPI65 (Low Dose)

UP165 (High Dose) OTHER

Red colored Capsules

UPI65 (High Dose)

Placebo OTHER

Red colored Capsules

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects diagnosed with sleep disorders secondary to another health problem.
• 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
• Students having regular class and assignments
• Subjects addicted to digital media who exhibit at least five of the following symptoms currently:
• i) 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,

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (6)

V.S. General Hospital

Ahmedabad, Gujarat, 380006, India

Location

Aman Hospital and Research Center

Vadodara, Gujarat, 390021, India

Location

Poojan Multispeciality Hospital

Ahmedabad, Maharashtra, 380061, India

Location

Shree Ashirwad Hospital

Dombivali, Maharashtra, 421201, India

Location

Sai Cititcare

Ulhasnagar, Maharashtra, 421004, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, 302039, India

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Envelope Blinding Chits
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double blind, placebo controlled, parallel group

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 20, 2023
• Study Start: May 4, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

IN (6)