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CTRI Number  CTRI/2022/06/043438 [Registered on: 22/06/2022] Trial Registered Prospectively
Last Modified On: 15/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   1 Follow up to assess if any effects of advised lifestyle modifications 
Study Design  Single Arm Study 
Public Title of Study   Survey study of the effects of suppression of sleep amongst night shift security guards by advicing lifestyle changes according to Ayurveda. 
Scientific Title of Study   An Observational study of Swasthavritta Regime to mitigate the effects of Nidra Vegavrodha in Security Guards working in night shift. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rutuja Ajit Ingale 
Designation  PG Student 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar 
Address  OPD No 4 Department of Swashthavritta, Sane Guruji Arogya Kendra, Hadapsar 28
OPD No 4 Department of Swashthavritta, Sane Guruji Arogya Kendra, Hadapsar 28
Pune
MAHARASHTRA
411037
India 
Phone  7030087868  
Fax    
Email  rutujaingale344@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Ujwale 
Designation  HOD Department of Swasthavritta and Yoga 
Affiliation  MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar 
Address  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar

Pune
MAHARASHTRA
411028
India 
Phone  9922008027  
Fax    
Email  ujwale_rs@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Ujwale 
Designation  HOD Department of Swasthavritta and Yoga 
Affiliation  MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar 
Address  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar

Pune
MAHARASHTRA
411028
India 
Phone  9922008027  
Fax    
Email  ujwale_rs@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Swasthavritta and Yoga,Malwadi,Hadapsar Pune 28 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune 28 
Type of Sponsor  Research institution and hospital 
 
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 Rutuja Ingale  Sane Guruji Arogya Kendra   OPD No 4, Department of Swasthavritta, Sane Guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA 		 7030087868

rutujaingale344@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All male security guards within the age group 25-50 years working in night shift duties for more than a month in this profession. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1)Community group - Security guards
2)Security guards must have been working in night shift duties for more than one month in this profession. 
 
ExclusionCriteria 
Details  1)Security guards using any sleep medication (sedative or tranquilizer)
2)Subjects unwilling to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It would be proved whether Swashavritta Regime mitigates the effects of Nidra Vegavrodha in Security Guards working in Nights shifts in one year.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
This study can be helpful to develop preventive guidelines
and some suggestions for Nidra vegavrodha symptoms and
to prevent the further complications of these symptoms. 		 1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   27/06/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Ayurveda has mentioned various principles for well-being of human and has mainly aimed at maintaining the healthy status of human being and secondly to cure disease. The 3 pillars are Aahar (diet), Nidra (sleep) and Brahmacharya (celibacy). If these 3 are observed properly with Yukti, they support the body and make it Stheer (Upastambha). In today’s era, changing lifestyle have significant effect on a person’s health. Daily regimen like sleep patterns and food habits change according to necessity. In this view, as a part of occupation, security guards of societies, hospital, banks etc. often stay awake at night due to night duties which often affects their health. Keeping awake at night causes increase in the Vata and Pitta Dosha. Increase in these factors may lead into the symptoms or diseases related to them. Staying awake at night causes an imbalance in healthy rhythm of body. A normal healthy pattern especially timely sleep and awakening ensures good health. Ayurveda Samhitas explain different types of Lakshanas arising due to suppression of natural urge of sleep i.e., Nidra Vegavrodha. In running life for some reasons like workload, nightshift duties etc. peoples suppress sleep natural urge (Nidra-adharniyavega) which leads to pathological states or disease. Nidra Vegavrodha is most important problem occurring in present lifestyle. Sleep deprivation occurs when someone does not get a healthy amount of sleep. The National Sleep Foundation (NSF) 2015 has recommended appropriate sleep durations for specific age groups. Among that, the necessary sleep duration for adults (18-64 age) is 7 – 8 hours/day. It is explained in Ayurveda Samhitas that avoiding the natural urge of Nidra causes increase in Vata and Pitta Dosha and may result in various symptoms further leading to diseases.  This study can be helpful to observe the ill effects of Nidra Vegavrodha Lakshanas in Security Guards as per textual references.  In addition, the study can evaluate the awareness about natural necessary sleep i. e. Ratriswabhavprabhava Nidra.  This study can be helpful to develop preventive guidelines and some suggestions for Nidra vegavrodha lakshanas and to prevent the further complications of these Lakshanas.
 
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