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CTRI Number  CTRI/2025/05/086650 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
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 Clinical study of a Sleep Support Supplement in improving Sleep Quality and reducing sleep problems 
Scientific Title of Study   A randomized, double blind, placebo controlled clinical study to evaluate the safety and efficacy of a Sleep Support Supplement (GPLIFE/PROD/2025/007) in improving sleep quality and alleviating symptoms associated with sleep disorders 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/003 Version: 1.00 dated 12 April 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre  
Address  Fourth-floor, OPD 401-314 B, Telco Road, Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shridhar J Pandya  
Designation  Director  
Affiliation  Gplife Healthcare Pvt. Ltd.  
Address  705-706, Orbit-1 Building, Punagum- Saroli Road, Near RRTM Market

Surat
GUJARAT
395010
India 
Phone  9824917109  
Fax  -  
Email  gplifehealthcare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dheeraj H Nagore 
Designation  Director  
Affiliation  Mprex Healthcare Pvt. Ltd 
Address  Office Number 813-816 Sai Millenium, Mumbai Pune BypassRoad Flyover, Punawale

Pune
MAHARASHTRA
411033
India 
Phone  09158791967  
Fax  -  
Email  dheeraj@mprex.in  
 
Source of Monetary or Material Support  
Gplife Healthcare Pvt. Ltd. 705-706, Orbit-1 Building, Punagum-Saroli Road, Near RRTM Market, Surat- 395010, Gujarat, India  
 
Primary Sponsor  
Name  Dr Chetan H Savaliya  
Address  Gplife Healthcare Pvt. Ltd. 705-706, Orbit-1 Building, Punagum-Saroli Road, Near RRTM Market, Surat, 395010, Gujarat, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital   Fourth Floor OPD 401, 314 B Telco Road, Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G479||Sleep disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  1 Tablet at night, 30 minute before sleep 
Intervention  Sleep Support Supplement (GPLIFE/PROD/2025/007)  1 Tablet at night, 30 minute before sleep 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Participants meeting all the following criteria will be eligible for the study:
1.Male and female participants aged 21 to 50 years (both inclusive);
2.Suffering from self-reported mild to moderate stress on the PSS scale score less than and equals to 26;
3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form;
4.Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR);
5.Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate;
6.Participants with a diagnosis of mild or moderate depression (patients’ health questionnaire (PHQ 9) score of less than and equals to 14);
7.Participants with a diagnosis of mild or moderate generalized anxiety disorder (GAD) 7 questionnaire score of less than and equals to 10.
 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria will not be eligible for the study:
1.Difficulty sleeping due to a medical condition;
2.History of a neurological disorder;
3.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication;
4.On going depression and generalized anxiety disorder (diagnosis on PHQ 9 score greater than and equals to 15 and GAD-7 score greater than and equals to 11 scales);
5.History of substance abuse or dependence;
6.History or current evidence of a clinically significant cardiovascular disorder at pre-study visit;
7.Taking certain prohibited medications;
8.Consumption of greater than 10 cigarettes a day;
9.current evidence or history of malignancy less than and equals to 5 years prior to signing informed consent;
10.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management;
11.Known hypersensitivity to any ingredients of product;
12.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study;
13.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Changes in Pittsburgh Sleep Quality Index (PSQI) score at screening and end of the study.
2.Changes in outcomes from participant sleep diary (total sleep time, sleep latency, number of awakenings, wake time after sleep onset and sleep efficiency.
3.Changes in Profile of Mood State abbreviated version (POMS A) score.
4.Changes in Insomnia Symptom Questionnaire (ISQ) score.
 		 Screening, Visit 1, Visit 2 and Visit 3
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in perceived stress scale (PSS) score.
2.Safety parameters (CBC, LFT and RFT).
3.Assessment of adverse events.
4.Assessment of treatment compliance and tolerability of investigational.
5.Assessment of changes in vital sign parameters.
 		 Screening, Visit 1, Visit 2 and Visit 3 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a sleep Support Supplement (GPLIFE/PROD/2025/007) in improving sleep quality and alleviating symptoms associated with sleep disorders in adults. A total of 60 male and female participants, aged 21 to 50 years, diagnosed with mild to moderate insomnia and other symptoms related to sleep disorders, will be enrolled and randomized into either the test group (receiving the sleep care formula) or the placebo group. Each participant will undergo treatment for 30 days, with scheduled visits at screening, visit 1-baseline (day 1), visit 2- day 15 (±5 days), and visit 3- day 30 (±5 days). The primary endpoints include changes in Pittsburgh Sleep Quality Index (PSQI) scores and sleep diary outcomes such as total sleep time, sleep latency, number of awakenings, wake time after sleep onset, and sleep efficiency. Secondary measures include changes in Profile of Mood States (POMS-A), Insomnia Symptom Questionnaire (ISQ), and Perceived Stress Scale (PSS) scores. Additional assessments involve vital signs, clinical laboratory investigations (CBC, LFT, RFT), adverse event monitoring, and evaluation of treatment compliance and tolerability. Participants with significant medical or psychiatric conditions, recent use of sleep or stress-related therapies, substance abuse, or other confounding factors will be excluded. This study aims to generate clinical evidence supporting the safety and effectiveness of a natural sleep care formula as a standalone intervention for individuals experiencing sleep disturbances and stress-related symptoms.


 
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