Clinical trial NCT05821049: A Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Keywords: Sleep Quality
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double blind, placebo controlled, parallel group
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: throughout the study period (approximately 28 days)
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 28
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 21
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 14
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 7
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 28
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 21
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 14
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 7
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 28
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 21
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 14
measure: To assess the efficacy of the Investigational Product (IP) from baseline on
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: V.S. General Hospital
state: Gujarat
city: Vadodara
country: India
facility: Aman Hospital and Research Center
state: Gujarat
city: Ahmedabad
country: India
facility: Poojan Multispeciality Hospital
state: Maharashtra
city: Dombivli
country: India
facility: Shree Ashirwad Hospital
state: Maharashtra
city: Ulhasnagar
country: India
facility: Sai Cititcare
state: Maharashtra
city: Jaipur
country: India
facility: Maharaja Agrasen Superspeciality Hospital
state: Rajasthan
Study officials:
References: