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CTRI Number  CTRI/2020/08/027048 [Registered on: 09/08/2020] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga for Police personnel 
Scientific Title of Study   Assessment of Pranayama and Yoga Nidra on mental health and quality of life among Police personnel during COVID-19 pandemic 
Trial Acronym  COVID-19 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Patil NJ 
Designation  Associate Professor and incharge Head 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research Kolar 
Address  Dept. of Integrative Medicine, Sri Devaraj Urs Academy of Higher Education and Research (Deemed to be University) Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886211008  
Fax    
Email  ayushnitin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Patil NJ 
Designation  Associate Professor and incharge Head 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research Kolar 
Address  Dept. of Integrative Medicine, Sri Devaraj Urs Academy of Higher Education and Research (Deemed to be University) Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886211008  
Fax    
Email  ayushnitin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Patil NJ 
Designation  Associate Professor and incharge Head 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research Kolar 
Address  Dept. of Integrative Medicine, Sri Devaraj Urs Academy of Higher Education and Research (Deemed to be University) Kolar

Kolar
KARNATAKA
563103
India 
Phone  9886211008  
Fax    
Email  ayushnitin@gmail.com  
 
Source of Monetary or Material Support  
Dr. Patil NJ Dept of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka Pin - 563103 Email: ayushnitin@gmail.com Mob: 98862 11008 
 
Primary Sponsor  
Name  Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka 
Address  Dept of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka 
Type of Sponsor  Other [A Deemed to be University ] 
 
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 Patil NJ  R L Jalappa Hospital and Research Center Tamaka Kolar  Room No 412, Fourth Floor Dept. of Integrative Medicine
Kolar
KARNATAKA 		 9886211008

ayushnitin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Devaraj Urs Medical College Kolar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Police personnel working during COVID-19 pandemic  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pranayama and Yoga Nidra in addition to Routine activities   Pranayama Kaphalbhati kriya (Preparatory) Nadishuddhi Bhramari pranayama, Nadanusandhana Yoga Nidra Duration: 40 minutes Frequency: 5 days a week for 6 weeks 
Comparator Agent  Routine activities   Routine activities  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Police personnel having at least one month of COVID-19 pandemic related duty.
2.Age 21 to 50 years
3.Perceived stress scale score 14 and above.

 
 
ExclusionCriteria 
Details  1.Practiced Yoga in last 3 months
2.Underwent recent surgery

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Depression, Anxiety, Stress scale-21 (DASS-21)
Fear of COVID-19 Scale
Perceived Stress Scale (PSS)
Pittsburgh Sleep Quality Index (PSQI)
 		 1st Day / Baseline
6th Week 
 
Secondary Outcome  
Outcome  TimePoints 
WHO Quality of Life – BREF (WHOQOL-BREF)  1st Day / Baseline
6th Week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/08/2020 
Date of Study Completion (India) 30/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary    World faces a stressful time with the rise of highly infectious coronavirus disease 2019 (COVID 19) pandemic.  Outbreak of COVID-19 was first seen in Wuhan, China. It is caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2). The modes of transmission are airborne, fomites, and droplet borne.  Lack of vaccination and specific treatment forced more emphasize on preventive measures, which includes social distancing, wearing mask, maintain hygiene etc. Frontline warriors including police personnel playing an important role in implementing the preventive measures on ground. Earlier both centre and state government enforced lockdown in four phases between 22nd  March to 31st May 2020  the implementation of the same was led by police personnel. The nature of work of police personnel further disturbed the psychosocial (Stress, anxiety, sleep, quality of life etc.) health. Literature recommends use of psychosocial intervention will help in these scenarios.

Yoga is an ancient Indian philosophy, emerged as evidence based complementary therapy in dealing with psychosomatic ailments. A growing body of scientific evidences in the field of Yoga found beneficial in the management of stress, anxiety, sleep and quality of life. AYUSH ministry, Government of India recommended regular practice of Yoga as one of the prophylactic measures for COVID-19 pandemic, which may enhance physical and psychological wellbeing. Yoga may be used as adjuvant therapy in COVID-19 infection and post COVID-19 rehabilitation. The present study is an attempt to explore the effect of integrated Yoga on Police personnel working during covid-19 pandemic .

 
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