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CTRI Number  CTRI/2024/07/071254 [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 study of De-Stress & Chill Gummies in reducing stress 
Scientific Title of Study   A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Chill Gummies in reducing stress and anxiety, and improving mood in adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/016 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

Mumbai
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

Mumbai
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 and anxiety 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  De-Stress and Chill Gummies-I001  Two gummies in sequence daily after meal for 60 days 
Intervention  De-Stress and Chill Gummies-U001  Two gummies in sequence daily after meal for 60 days 
Comparator Agent  Placebo Gummies-001  Two gummies in sequence daily after meal 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.No severe anxiety and depression ie Generalized anxiety disorder GAD score less than or equal to 10 and Patients’ health questionnaire-9 PHQ-9 score less than or equal to 14 5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period 6.No history of substance use disorder other than use of nicotine and recreational use of alcohol not having used for the last 14 days and consenting not to use the same during the period of the trial 7.Willing to limit caffeine consumption while in the study.  
 
ExclusionCriteria 
Details  1.Inability to perform any of the assessments required for endpoint analysis
2.Shows signs of dementia, such as caused by Alzheimer’s Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH)
3.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
4.Have any other neurodegenerative diseases or seizure disorder
5.Known hypersensitivity to investigational products
6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
7.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
8.Sitting or resting systolic blood pressure more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg at screening
9.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
10.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study. 
 
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) score, LDH and creatine kinase levels, body weight and BMI, mental chatter score assessed by 5 point scale, Hamilton Anxiety Rating Scale (HAM-A) score, COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, visual analogue scale score- for evaluation of fatigue, nausea, palpitation, breathlessness
2.Changes in serum cortisol levels
3.Change in serum serotonin levels
4.Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ) score.
5.Changes in Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression), visual analogue scale score.
 		 1.Screening day 30, and day 60
2.Screening, day 15 and day 60
3.Screening, day 30 and day 45
4.After stopping treatment for 1 week (day 68)
5.Screening, day 15, day 30 and day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes are as follows-1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters.
2.Assessment of 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="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/08/2024 
Date of Study Completion (India) 30/05/2025 
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 reduction of stress,anxiety and improving mood in adults. Adults experiencing chronic stress and anxiety often suffer from a reduced quality of life, marked by symptoms such as irritability, fatigue, and difficulty concentrating. By integrating these gummies into their daily routine, many report noticeable improvements in their emotional and mental state. These enhancements can manifest as increased energy levels, better sleep quality, and a more balanced mood, which collectively contribute to a more positive outlook on life. 
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