| CTRI Number |
CTRI/2020/11/028827 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga program on COVID 19 patients |
|
Scientific Title of Study
|
Effect of an integrated Yoga program on stress, mood states, sleep quality, symptom severity, quality of life and clinical outcomes in Covid19 positive patients undergoing conventional treatment : a Multicentric trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavendra Rao M |
| Designation |
Director |
| Affiliation |
Central Council for Research in Yoga & Naturopathy (CCRYN) |
| Address |
Department of Research, Division of Yoga, Room No. 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9916488864 |
| Fax |
|
| Email |
ccryn.director@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Rao M |
| Designation |
Director |
| Affiliation |
Central Council for Research in Yoga & Naturopathy (CCRYN) |
| Address |
Department of Research, Division of Yoga, Room No. 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9916488864 |
| Fax |
|
| Email |
ccryn.director@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra Rao M |
| Designation |
Director |
| Affiliation |
Central Council for Research in Yoga & Naturopathy (CCRYN) |
| Address |
Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9916488864 |
| Fax |
|
| Email |
ccryn.director@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga and Naturopathy Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH |
| Address |
61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak KK |
AIIMS, New Delhi |
Room no 2 Dept of Physiology st floor Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
8368293571
kkdeepak@gmail.com |
| Dr Minakshi Dhar |
AIIMS, Rishikesh |
Virbhadra rd, Shivajinagar, near barrage, Sturida colony, Rishikesh, Uttarakhand 249203
Hardwar
UTTARANCHAL |
7060002778
minakshi.dhar@rediffmail.com |
| Dr Sudheer |
Chinmaya Mission Hospital |
CMH Rd, Bangalore
Bangalore
KARNATAKA |
9343717385
cmhblr@rediffmail.com |
| Dr Amit Agarwal |
Dr Ram Manohar Lohia Hospital |
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi,
Central
DELHI |
9716112232
amitaggarwal@doctor.com |
| Dr Sunitha Mondal |
Lady Hardinge Medical College and Hospital |
Shivaji Stadium, Connaught place, New Delhi 110093
Central
DELHI |
9312363298
dr_sunitam@yahoo.co.in |
| Dr Chhavi Gupta |
Rajiv Gandhi Super Speciality Hospital |
Taharpur rd, Taharpur village, Dilshad Garden New Delhi
South
DELHI |
9899207036
drchhavigupta.rgssh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institute Ethics committee -AIIMS, Rishikesh |
Submittted/Under Review |
| Institute Ethics committee All India Institute of Medical sciences |
Approved |
| Institutional Ethics Committe -Dr Ram Manohar Lohia Hospital |
Submittted/Under Review |
| Institutional Ethics Committe-Chinmaya Mission Hospital |
Submittted/Under Review |
| Institutional Ethics Committe-Lady Hardinge Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committe-Rajiv Gandhi Super Speciality Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Covid 19 patients take part in control group receive standard care following admission to a tertiary Covid 19 screening and treatment center. |
They will also receive counselling to allay their anxiety in addition to their routine treatment |
| Intervention |
Test Group: Integrated biofeedback based yoga program
Covid 19 patients take part in a 2 week Integrated biofeedback based yoga program following admission to a tertiary Covid 19 screening and treatment center
|
Patients are asked to practice 3-4 times a day over a 14-day period with each session lasting over 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Covid 19 positive case diagnosed using RT PCR in authorized Covid19 testing facility
2.Mild clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)
3.Presenting with or without flu symptoms
4.Aged 18-60 years
5.High school education
6.Written consent to participate in any arm of the study
7.Those having a smart phone mobile device with android or IOS operating system.
|
|
| ExclusionCriteria |
| Details |
1.Severe infection News-3-4 requiring admission to ICU.
2.Unable to take oral medication,
3.Immunocompromised,
4.Creatinine clearance (CCL) < 30 ml/min,
5.Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN),
6.d-dimer > 2microgram per liter, or
7.Uncontrolled diabetes, Hypertension, Existing Heart disease and heart failure, any cancer, autoimmune disease, stroke, neurodegenerative diseases etc..
8.Clinical condition that reduces survival to less than six months.
9.Pregnancy and lactating mothers
10.Clinical signs suggestive of septicemia and multi organ dysfunction.
11. Score of less than 24 points on the Folstein Mini-Mental State Examination(43).
12.Score of more than 14 points on the 9-item Patient Health Questionnaire (PHQ-9) depression screen (44).
13.BMI less than 18
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be defined as area-under-the curve global severity for all ARI illness days throughout observation, from consent to study exit |
Day 0 to study exit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to discharge/recovery: Discharge/recovery, ICU admissions and Death will be considered events. Time to event analysis will be carried out as one of the outcomes. Will be a study endpoint.
2. Biomarkers: With each ARI illness episode, a nasal wash /throat swab will be collected in VTB medium within 3 days of symptom onset and analyzed for covid 19 using Multiplex polymerase chain reaction (PCR) This test will be done at baseline and 14 days.
|
Day 0 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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)?
|
|
Brief Summary
|
The anxiety and uncertainty about the trajectory and course of illness among the Covid 19 positive patients can lead to psychologic distress that can down regulate their immune defenses and increase the chance and severity of infection. Studies have shown psychologic stress to enhance the rates of infection in communities during a flu season. Studies have also shown mind body interventions such as exercise(), meditation and yoga to reduce infection rates in communities during a seasonal flu. Experience from China has shown that providing psychological treatment and support may reduce the burden of comorbid mental health conditions and ensure the wellbeing of those affected). However, Covid 19 is highly infectious warranting isolation of the patient. In this study we will test the efficacy of a mobile app based yoga intervention along with non-obtrusive and non-contact monitoring of patient’s vitals using a novel sensor technology (dozee) developed by IITians to measure vitals, psychologic distress and relaxation response. This is achieved through a sensor mat that is placed below the patient’s mattress. We will evaluate the role of yoga intervention (pranayama and relaxation) in reducing symptom scores, self-reported stress, mood and quality of life. We will also assess if yoga intervention helped reduce stress (using heart rate variability), improve sleep and vitals in this population. T |