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CTRI Number  CTRI/2024/07/071253 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 17/01/2025
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 trial of De-Stress & Snooze Gummies in reducing stress and insomnia disorder. 
Scientific Title of Study   A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms and oveall quality of life. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/019 Ver. 1.00 Dated 25-June-2024  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 and Hospital 
Address  Room no 401 OPD Fourth floor 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 Kriti Soni 
Designation  Global Head R and D 
Affiliation  Herbolab India Pvt. Ltd. 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East

Pune
MAHARASHTRA
400072
India 
Phone  9871018383  
Fax  -  
Email  kriti.soni@rpsg.in  
 
Details of Contact Person
Public Query  
Name  Dr Kriti Soni 
Designation  Global Head R and D 
Affiliation  Herbolab India Pvt. Ltd. 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East

Pune
MAHARASHTRA
400072
India 
Phone  9871018383  
Fax  -  
Email  kriti.soni@rpsg.in  
 
Source of Monetary or Material Support  
Herbolab India Pvt Ltd Floor - 6th, F-15 ,Plot 78, Commerce Centre, Pandit Madan Mohan Malviya Marg, Tardeo, Mumbai, 400034 
 
Primary Sponsor  
Name  Herbolab India Pvt Ltd 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East MUMBAI, MAHARASHTRA, 400072. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagar Adhatrao   Ayushri Multispeciality Hospital  Samadhan chowk, Pimprigaon, Pimpri
Pune
MAHARASHTRA 		 9665802704
-
drsagara.ayushrihospital@gmail.com  
Dr Ramshyam Agarwal   Lokmanya Medical Research Centre and Hospital  Room no 401 OPD Fourth-floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  stress, insomnia disorder, associated symptoms  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  De-Stress & Snooze Gummies-I001  Two gummies daily in sequence 30-45 minutes before bed for 60 days 
Intervention  De-Stress & Snooze Gummies-U001  Two gummies daily in sequence 30-45 minutes before bed for 60 days 
Comparator Agent  Placebo Gummies 002  Two gummies daily in sequence 30-45 minutes before bed for 60 days 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Male and female participants aged 21-50 years both inclusive 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal 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 patient’s health questionnaire PHQ-9 score of less than or equal to 14 7.Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10. 
 
ExclusionCriteria 
Details  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 or equal to 15 and GAD-7 score greater than or equal 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.Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study
10.Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent
11.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management
12.Known hypersensitivity to any ingredients of product
13.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
14.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 
Primary outcomes are as follows 1.Changes in perceived stress scale (PSS), Restorative Sleep Questionnaire score-Weekly Version (RSQ-W), Changes in under-eye dark circles for four zones and graded on a bespoke scale, visual analogue score for headache.
2.Changes in outcomes from participant sleep diary, Sleep efficiency, overall sleep score by actigraphy for 10 subjects
3.Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
4.Changes in serum cortisol levels at screening, day 15 and day 60
5.Changes in serum serotonin levels at screening, day 30 and day 45
6.Changes in Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Mood State abbreviated version (POMS-A) score  		 1.Screening, day 30 and day 60
2.Baseline, day 30 ad day 60
3.Score after stopping treatment for 1 week (day 68)
4.Screening, day 15 and day 60
5.Screening, day 30 and day 45
6.Screening and day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes are as follows- 1. Assessment of adverse events, treatment compliance and tolerability of investigational products throughout the study 2.Assessment of changes in vital sign parameters, changes in complete blood count, liver function test and kidney function test.  1.Screening, baseline, day 15, day 30, day 45, day 60, to end of the study
2.Screening and day 60 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/08/2024 
Date of Study Completion (India) 14/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a good night’s sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind. 
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