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

NCT ID: NCT05821049

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2023-12-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

UPI65 (Low Dose)

One capsule to be taken 60 ± 10 mins before bed

Group Type: ACTIVE_COMPARATOR

UPI65 (Low Dose)

Intervention Type: OTHER

Red colored Capsules

UPI65 (High Dose)

One capsule to be taken 60 ± 10 mins before bed

Group Type: ACTIVE_COMPARATOR

UP165 (High Dose)

Intervention Type: OTHER

Red colored Capsules

Placebo

One capsule to be taken 60 ± 10 mins before bed

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Red colored Capsules

Interventions

UPI65 (Low Dose)

Red colored Capsules

Intervention Type: OTHER

UP165 (High Dose)

Red colored Capsules

Intervention Type: OTHER

Placebo

Red colored Capsules

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

V.S. General Hospital

Ahmedabad, Gujarat, India

Aman Hospital and Research Center

Vadodara, Gujarat, India

Poojan Multispeciality Hospital

Ahmedabad, Maharashtra, India

Shree Ashirwad Hospital

Dombivali, Maharashtra, India

Sai Cititcare

Ulhasnagar, Maharashtra, India

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, India

Countries

India

Other Identifiers

UI/220902/UP/SQMS

Identifier Type: -

Identifier Source: org_study_id