CompletedNot Applicable

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

India175 participantsStarted 2023-05-04

Plain-language 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

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: throughout the study period (approximately 28 days)

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

Timeframe: Day 28

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

Timeframe: Day 21

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

Timeframe: Day 14

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

Timeframe: Day 7

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

Timeframe: Day 28

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

Timeframe: Day 21

Trial details

NCT IDNCT05821049

SponsorVedic Lifesciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-08

View on ClinicalTrials.gov More Sleep Disturbance trials

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: throughout the study period (approximately 28 days)

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

Timeframe: Day 28

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

Timeframe: Day 21

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

Timeframe: Day 14

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

Timeframe: Day 7

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

Timeframe: Day 28

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

Timeframe: Day 21