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CTRI Number  CTRI/2021/04/032845 [Registered on: 15/04/2021] Trial Registered Prospectively
Last Modified On: 13/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Yoga interventions for the management of COVID 19 in asymptomatic patients  
Scientific Title of Study   Yoga interventions for the management of COVID 19 in asymptomatic patients: A mixed method study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R ARCHANA 
Designation  VICE DEAN RESEARCH AND PROFESSOR 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM

Kancheepuram
TAMIL NADU
602105
India 
Phone  09840608149  
Fax    
Email  dr.rarchana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  R ARCHANA 
Designation  VICE DEAN RESEARCH AND PROFESSOR 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM

Kancheepuram
TAMIL NADU
602105
India 
Phone  09840608149  
Fax    
Email  dr.rarchana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  R ARCHANA 
Designation  VICE DEAN RESEARCH AND PROFESSOR 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM

Kancheepuram
TAMIL NADU
602105
India 
Phone  09840608149  
Fax    
Email  dr.rarchana@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM 
 
Primary Sponsor  
Name  R ARCHANA 
Address  SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM 
Type of Sponsor  Other [other (self)] 
 
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 
R Archana  SAVEETHA MEDICAL COLLEGE AND HOSPITAL  Department of Physiology 1st floor, Room No: 03, Saveetha Medical College and Hospital, Thandalam
Chennai
TAMIL NADU 
9840608149

dr.rarchana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  yoga   1. Simple pranayama – Sheetali & Bhramari Pranayama (10 minutes) 2. Yoga nidra (10 minutes)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All willing Male and Female adult patients ≥18 years and ≤60 years of age at the time of recruitment 
 
ExclusionCriteria 
Details  Explicit non-willingness to be a part of the research study
Patients with Severe Acute respiratory Distress syndrome and who were already practicing yoga or meditation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Information on whether Yoga intervention have any impact of COVID 19 patients in terms of reduction of symptoms, and reduction in mental stress, anxiety or depression
 
3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Preliminary results from this exploratory study may provide evidence for future confirmatory research studies.
 
3 months 
 
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   N/A 
Date of First Enrollment (India)   08/05/2021 
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   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

       The global impact of Covid19 has been profound and the health threat that it presents to the individual, the national economy and the healthcare delivery systems are estimated to be more serious than most of the other pandemics in the modern times (1). Being a new viral infection, as on date there are no proven preventive or therapeutic regime available. The vaccines or drug regimens are in various stages of evaluation (2). One fundamental principle of Yoga is that the body heals itself and duty of the physician is to aid the self-healing process i.e. salutogenesis. Yoga interventions in a variety of conditions has documented to improve quality of life, reduce mental health related problems such as stress, anxiety & depression in a wide spectrum of illness (3).

The aim of our study is to assess the effect of Yoga intervention on management of depression, anxiety, stress, sleep quality and overall quality of life in asymptomatic COVID19 patients. It is a Quasi Experimental study (Pre post design) with a sample size of 60 COVID19 asymptomatic patients who are part of the Saveetha Home care program of Saveetha Medical College and Hospital. They will be recruited for the study and will be informed about the significance of yoga intervention. Prior to the intervention, the training for yoga practice will be given via Zoom meeting and it will be made sure that the subject has correctly learnt all the steps involved in the intervention. The three-month yoga practice will be given as a video recording and shared in whatsapp group and the patients practice will be monitored in Whatsapp daily, morning and evening for 14days. The pre and post values of depression, anxiety, stress, perceived stress, sleep quality and quality of life will be assessed using google form questionnaires, Quality of life as assessed by WHO-QoL BREF (4), DASS-21 for assessing depression & anxiety (5), Perceived Stress Scale for stress (6), Pittsburgh Sleep Quality Index (PSQI) for sleep (7). The statistical analysis will be done using SPSS 17.0. The pre and post data will be analyzed using paired t test. P values less than 0.05 will be accepted as indicator for significant differences between the data.

       The expected outcome of the project is that the Practice of yoga will be effective in reducing stress, anxiety, depression and improving the quality of life and quality of sleep in asymptomatic COVID 19 patients in the saveetha home care system.

Reference:

1.Ferguson, N. M., Laydon, D., Nedjati-Gilani, G., Imai, N., Ainslie, K., Baguelin, M., & Dighe, A. (2020). Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand. Imperial College COVID-19 Response Team.

2.Cramer H, Lauche R, Anheyer D, Pilkington K, de Manincor M, Dobos G, Ward L. Yoga for anxiety: A systematic review and meta‐analysis of randomized controlled trials. Depression and anxiety. 2018 Sep;35(9):830-43.

3.Thanalakshmi J, Maheshkumar K, Kannan R, Sundareswaran L, Venugopal V, Poonguzhali S. Effect of Sheetali pranayama on cardiac autonomic function among patients with primary hypertension-A randomized controlled trial. Complementary Therapies in Clinical Practice. 2020 Mar 5:101138.

4.World Health Organization. Division of Mental Health. (‎1996)‎. WHOQOL-BREF : introduction, administration, scoring and generic version of the assessment : field trial version, December 1996. World Health Organization

5.Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety & Stress Scales. (2nd Ed.)Sydney: Psychology Foundation.

6.Cohen, S., Kamarck, T., and Mermelstein, R.(1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396.

7.Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research. 1989;28(2):193–213.


 
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