| CTRI Number |
CTRI/2023/04/051364 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of Investigational Product on sleep quality and mood state in healthy adults |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| UI/220902/UP/SQMS, 1.0, 17th February, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai
400053, India
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai
400053, India
Mumbai
MAHARASHTRA
400053
India
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhimanyu Kumar |
| Designation |
Project Lead |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai
400053, India
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172325 |
| Fax |
|
| Email |
abhimanyu.s@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd, B-118, Morya House, Veera Desai Industrial Estate, Andheri West, Mumbai - 400053. |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai
400053, India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mallika Aman Khanna |
Aman Hospital and Research Center |
15 Shashwat, Opp E.S.I Hospital, Gotri Road, Vadodara-390021
Vadodara
GUJARAT |
0265-2354594
mallsaman06@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidhyadhar Nagar, Jaipur - 302039
Jaipur
RAJASTHAN |
9983995050
pksharma.clinical@gmail.com |
| Dr Ronak Shah |
Poojan Multispeciality Hospital |
1st Floor, Navnidhi Avenue, Nr. A - 1 Schoool, Subhash Chowk, Gurukul, Ahmedabad - 380052, Gujarat.
Ahmadabad
GUJARAT |
9898783040
poojan.research@gmail.com |
| Dr Prakash Kaurani |
Sai Criticare |
Block C-1, Opp Roshan Apt Venus, Netaji Road, Ulhasnagar, Thane Maharashtra, 421004
Thane
MAHARASHTRA |
9766260204
tpa.saicriticare@gmail.com |
| Dr Kushal Bangar |
Shree Ashirwad Hospital |
C-3, Shree Complex, Opposite Mahavir Nagar, Manpada Road, Dombivali, Maharashtra, India
Thane
MAHARASHTRA |
9545664884
drkushal.bangar83@gmail.com |
| Dr Dhaiwat Shukla |
V. S. General Hospital |
Near Ellisbridge, Paldi, Ahmedabad - 380006
Ahmadabad
GUJARAT |
8980024107
dr.dhaiwatshukla89@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics committee aman hospital and research centre. |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Riddhi Medical Nursing Home Intitutional Ethics Committee |
Approved |
| Sai Criticare Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep Quality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CMC |
1 capsule approximately 60 ± 10 mins before bed for 4 weeks |
| Intervention |
UP165 (250 mg) |
1 capsule approximately 60 ± 10 mins before bed for 4 weeks. |
| Intervention |
UPI65 (500 mg) |
1 capsule approximately 60 ± 10 mins before bed for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 body weight 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Sleep statistics by using the Garmin vivosmart 4 Tracker
|
1. Throughout the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI).
2. Mood using POMS-A (Profile of Moods States – Abbreviated version).
3. Salivary cortisol immediately after awakening |
1. Day 0, Day 7, Day 14, Day 21 and Day 28
2. Day 0, Day 7, Day 14, Day 21 and Day 28
3. Day 0, Day 7, Day 14, Day 21 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "175"
Final Enrollment numbers achieved (India)="175" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2023 |
| Date of Study Completion (India) |
08/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study randomized, placebo-controlled, parallel-group, double-blind (double-dummy) clinical study. Approximately 150 participants will be randomized in a ratio of 1:1:1 to receive UPI65 (Low Dose), UPI65 (High Dose), or Placebo . |