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

Primary Purpose

Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
UPI65 (Low Dose)
UP165 (High Dose)
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Disturbance focused on measuring Sleep Quality

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • V.S. General HospitalRecruiting
  • Aman Hospital and Research CenterRecruiting
  • Shree Ashirwad HospitalRecruiting
  • Sai CititcareRecruiting
  • Maharaja Agrasen Superspeciality HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

UPI65 (Low Dose)

UPI65 (High Dose)

Placebo

Arm Description

One capsule to be taken 60 ± 10 mins before bed

One capsule to be taken 60 ± 10 mins before bed

One capsule to be taken 60 ± 10 mins before bed

Outcomes

Primary Outcome Measures

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.
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)
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)
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)
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)
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
June 5, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05821049
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
November 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
Sleep Quality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double blind, placebo controlled, parallel group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Envelope Blinding Chits
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UPI65 (Low Dose)
Arm Type
Active Comparator
Arm Description
One capsule to be taken 60 ± 10 mins before bed
Arm Title
UPI65 (High Dose)
Arm Type
Active Comparator
Arm Description
One capsule to be taken 60 ± 10 mins before bed
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule to be taken 60 ± 10 mins before bed
Intervention Type
Other
Intervention Name(s)
UPI65 (Low Dose)
Intervention Description
Red colored Capsules
Intervention Type
Other
Intervention Name(s)
UP165 (High Dose)
Intervention Description
Red colored Capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Red colored Capsules
Primary Outcome Measure Information:
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
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)
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Day 28
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Day 21
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Day 14
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Day 7
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time Frame
Day 28
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time Frame
Day 21
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time Frame
Day 14
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Time Frame
Day 7
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time Frame
Day 28
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time Frame
Day 21
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time Frame
Day 14
Title
To assess the efficacy of the Investigational Product (IP) from baseline on
Description
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Srivastava, MBBS, MD
Phone
02242172300
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Abhimanyu Kumar Sharma
Phone
02242172325
Email
abhimanyu.s@vediclifesciences.com
Facility Information:
Facility Name
V.S. General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Dhaiwat Shukla, MBBS, MD
Phone
8980024107
Email
dr.dhaiwatshukla89@gmail.com
Facility Name
Aman Hospital and Research Center
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Mallika Aman Khanna, MBBS, MD (Medicine)
Phone
0265-2354594
Email
mallsaman06@gmail.com
Facility Name
Shree Ashirwad Hospital
City
Dombivli
State/Province
Maharashtra
ZIP/Postal Code
421201
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Kushal Bangar, M.B.B.S, DNB (Medicine)
Phone
9545664884
Email
drkushal.bangar83@gmail.com
Facility Name
Sai Cititcare
City
Ulhasnagar
State/Province
Maharashtra
ZIP/Postal Code
421004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Prakash Kaurani, M.D. Physician
Phone
9766260204
Email
tpa.saicriticare@gmail.com
Facility Name
Maharaja Agrasen Superspeciality Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302039
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Prabhat Kumar Sharma, MBBS, MD
Phone
9983995050
Email
pksharma.clinical@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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