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

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 Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Other: UPI65 (Low Dose); Other: UP165 (High Dose); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shalini Srivastava, MBBS, MD; Phone Number: 02242172300; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Mr. Abhimanyu Kumar Sharma; Phone Number: 02242172325; Email: abhimanyu.s@vediclifesciences.com

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • V.S. General Hospital
    • Vadodara, Gujarat, India, 390021
      • Aman Hospital and Research Center
      • Contact: Dr. Mallika Aman Khanna, MBBS, MD (Medicine); Phone Number: 0265-2354594; Email: mallsaman06@gmail.com
  • Maharashtra
    • Ahmedabad, Maharashtra, India, 380061
      • Poojan Multispeciality Hospital
    • Dombivli, Maharashtra, India, 421201
      • Shree Ashirwad Hospital
      • Contact: Dr. Kushal Bangar, M.B.B.S, DNB (Medicine); Phone Number: 9545664884; Email: drkushal.bangar83@gmail.com
    • Ulhasnagar, Maharashtra, India, 421004
      • Sai Cititcare
      • Contact: Dr. Prakash Kaurani, M.D. Physician; Phone Number: 9766260204; Email: tpa.saicriticare@gmail.com
  • Rajasthan
    • Jaipur, Rajasthan, India, 302039
      • Maharaja Agrasen Superspeciality Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UPI65 (Low Dose); One capsule to be taken 60 ± 10 mins before bed	Other: UPI65 (Low Dose); Red colored Capsules
Active Comparator: UPI65 (High Dose); One capsule to be taken 60 ± 10 mins before bed	Other: UP165 (High Dose); Red colored Capsules
Placebo Comparator: Placebo; One capsule to be taken 60 ± 10 mins before bed	Other: Placebo; Red colored Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	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)	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)	Day 7
To assess the efficacy of the Investigational Product (IP) from baseline on	Mood using POMS-A (Profile of Moods States - Abbreviated version)	Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on	Mood using POMS-A (Profile of Moods States - Abbreviated version)	Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on	Mood using POMS-A (Profile of Moods States - Abbreviated version)	Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on	Mood using POMS-A (Profile of Moods States - Abbreviated version)	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)	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)	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)	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)	Day 7

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Sleep Quality
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: UI/220902/UP/SQMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No