| CTRI Number |
CTRI/2020/10/028566 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for COVID-19 asymptomatic patients |
|
Scientific Title of Study
|
EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 ASYMPTOMATIC PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyapriya Maharana |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani,
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
8618587448 |
| Fax |
|
| Email |
trisatyapriya77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyapriya Maharana |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani,
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
8618587448 |
| Fax |
|
| Email |
trisatyapriya77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragya Jain Shrimal |
| Designation |
PhD Scholar(Yoga) |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Department of yoga and life science, Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9425187845 |
| Fax |
|
| Email |
pragyajain11@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1) MTH, Hospital Indore 2)Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
|
|
Primary Sponsor
|
| Name |
Pragya Jain Shrimal |
| Address |
220, clerk colony opp to Bhandari Hospital pardeshi pura, Indore (M.P.)-452003 |
| Type of Sponsor |
Other [Self Funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pragya Jain Shrimal |
MTH, Hospital |
Mahatma Gandhi Rd, Siyaganj, Indore
MADHYA PRADESH
Indore
MADHYA PRADESH |
9425187845
pragyajain11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SVYASA Bangalore |
Approved |
|
|
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 |
Control Group Participants - Routine care activity |
All participants in control group will follow Routine care activity . |
| Intervention |
Yoga modules for management of coronavirus disease 2019 |
Integrated tele based yoga intervention will consist of Breathing practices, Pranayama and Meditation. Tele based yoga intervention will be given for a period of 7 days, 30 minutes/day in which 15 minutes in everyday it will be practice under the observation of medical staff and 15 minutes they will do self-practice in the evening with the help of Television in their respective wards. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Only COVID-19 positives confirmed by RT-PCR method to be recruited.
2) Inclusion of COVID-19 asymptomatic patients as per WHO guidelines.
3) Inclusive of people under Quarantine under Government setup.
4) Inclusion of asymptomatic patients.
|
|
| ExclusionCriteria |
| Details |
1) Unwilling for participation.
2) Physical and mental disability.
3) Medical restriction for physical movement.
4) History of recent surgery.
5) Pregnant females.
6) Severe Comorbid conditions (uncontrolled Diabetes, Uncontrolled Hypertension and Cardiac diseases, COPD etc.). |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressure |
Day 1 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stress, COVID-19 Peritraumatic Distress and Mindfulness |
Day 1 and Day 7 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
31/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 is an infectious disease caused by recently
discovered novel coronavirus (World Health Organization, 2020a). Coronaviruses
are a large family of viruses which may cause illness in animals or humans. In
humans, several coronaviruses are known to cause respiratory infections ranging
from the common cold to more severe diseases such as Middle East Respiratory
Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) (National Health Mission, 2020). The most
recently discovered coronavirus causes coronavirus disease COVID-19 (World Health Organization, 2020).
As per WHO, COVID-19 has
affected 215 countries or territories or areas. Till 16th July
2020, there have been infected over 12,015,193 people of COVID-19, including
549,247 deaths reported Globally (World Health Organization, 2020c). In
India, COVID-19 has been infected 974,737 people
in which 331146 active
cases, 612814 recovery and
has claimed 24915 deaths,
as per the Ministry of Health and Family Welfare, Government of
India (Ministry of Health and Family Welfare, 2020).
Yoga as an add-on therapy may
support patients of COVID-19 by improving the quality of standard
care (Tillu et al., 2020).The Health advisory is given by The Ministry of
Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH)
against coronavirus infection included Practice of Yogasana, Pranayama
and meditation for at least 30 minutes every day for immunity-boosting
guidelines to supplement the fight against COVID-19 (Ayush Ministry,
2020). The Harvard Medical School in the US has recommended yoga,
meditation and controlled breathing to address anxiety issues related to the
novel coronavirus (Sharp, 2020). Yoga is an add‑on benefits of stress
management, as well as prevention and management of chronic non communicable
diseases and communicable diseases. Based on the available scientific evidences
on yoga in improving respiratory and immune functions. (Nagarathna et al.,
2020). Certain meditation, yoga asana (postures), and pranayama (breathing)
practices may possibly be effective adjunctive means of treating and/or
preventing SARS-CoV-2 infection (Bushell et al., 2020).
Hence there is a requirement of such a study which
provides integrated yoga based intervention in the scenario of COVID-19
pandemic. So this will be the study which is going to see the effect of short term
yogic intervention on COVID-19 asymptomatic
patients. |