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Completed

NCT Number: NCT05821049

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

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

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Key information

Conditions

Sleep Disturbance Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

V.S. General Hospital, Ahmedabad, Gujarat, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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,
  • 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.

Treatment and study plan

UPI65 (Low Dose)

Other

Red colored Capsules

UP165 (High Dose)

Other

Red colored Capsules

Placebo

Other

Red colored Capsules

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Day 28

    The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)

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

    Time frame: Day 21

    The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)

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

    Time frame: Day 14

    The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)

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

    Time frame: Day 7

    The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)

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

    Time frame: Day 28

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

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

    Time frame: Day 21

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

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

    Time frame: Day 14

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

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

    Time frame: Day 7

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

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

    Time frame: Day 28

    Salivary cortisol levels immediately after waking up in the morning (before doing any activity)

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

    Time frame: Day 21

    Salivary cortisol levels immediately after waking up in the morning (before doing any activity)

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

    Time frame: Day 14

    Salivary cortisol levels immediately after waking up in the morning (before doing any activity)

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

    Time frame: Day 7

    Salivary cortisol levels immediately after waking up in the morning (before doing any activity)

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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