CompletedNCT05821049Updated Apr 15, 2024

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

An interventional study of UPI65 (Low Dose) and UP165 (High Dose) in Sleep Disturbance, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 6 sites in India. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 175
Allocation: Randomized
Ages: 20 Years to 60 Years
Sex: All

Study 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 studied

Sleep Disturbance

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Keywords

Sleep Quality

In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's enrollment of 175 is above the median of 60 across 251 interventional studies indexed under Dyssomnias.

Browse Dyssomnias studies →

Lead sponsor

Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 60 Years
Sexes eligible: 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

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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 175 participants (actual)

Study arms

Active comparator
UPI65 (Low Dose)
One capsule to be taken 60 ± 10 mins before bed
Other: UPI65 (Low Dose)
Active comparator
UPI65 (High Dose)
One capsule to be taken 60 ± 10 mins before bed
Other: UP165 (High Dose)
Placebo comparator
Placebo
One capsule to be taken 60 ± 10 mins before bed
Other: Placebo

Interventions

OtherUPI65 (Low Dose)
Red colored Capsules
OtherUP165 (High Dose)
Red colored Capsules
OtherPlacebo
Red colored Capsules

What researchers measure

Primary outcomes

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
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

Study locations

6 sites

V.S. General Hospital
Ahmedabad, Gujarat 380006, India
Aman Hospital and Research Center
Vadodara, Gujarat 390021, India
Poojan Multispeciality Hospital
Ahmedabad, Maharashtra 380061, India
Shree Ashirwad Hospital
Dombivli, Maharashtra 421201, India
Sai Cititcare
Ulhasnagar, Maharashtra 421004, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan 302039, India

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05821049
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Responsible party: Sponsor
First posted: Apr 20, 2023
Start date: May 4, 2023
Primary completion: Dec 8, 2023
Completion: Dec 8, 2023
Last update: Apr 15, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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