| CTRI Number |
CTRI/2020/10/028486 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yoga for COVID-19 Patients with mild symptoms |
|
Scientific Title of Study
|
EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 PATIENTS WITH MILD SYMPTOMS |
| 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
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, No.19 Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar,
Bangalore - 560019
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
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, No.19 Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar,
Bangalore - 560019
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
220, Clerk Colony
Opp to Bhandari Hospital
Pardeshi Pura, Indore (Madhya Pradesha) - 452003
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.) |
| 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 452007
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 (Self-as-control) |
Patients will be given orientation of tele based yoga practice for a period of 4 days, for two sessions of 15 minutes each with the help of Television in their respective wards. In this, morning sessions of 15 minutes will be practice under the observation of medical staff and in the evening they will do self-practice for 15 minutes. After completing four days of familiarization of practices, on 5th day we will randomize the patients into two groups (Group A & Group B).On the 5th day Group B will do their routine activity of 15 minutes and on 6th day Group A will do their routine activity of 15 minutes. |
| Intervention |
Yoga modules for management of coronavirus disease 2019 (Self-as-control) |
Patients will be given orientation of tele based yoga practice for a period of 4 days, for two sessions of 15 minutes each with the help of Television in their respective wards. In this, morning sessions of 15 minutes will be practice under the observation of medical staff and in the evening they will do self-practice for 15 minutes. After completing four days of familiarization of practices, on 5th day we will randomize the patients into two groups (Group A & Group B). On the 5th day Group A will be given 15 minutes of tele based yoga intervention and on 6th day Group B will be given 15 minutes tele based yoga intervention. |
|
|
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)Patients who are affected by the coronavirus (COVID-19) and are in hospital confinement.
3) Patients with mild symptoms which may include: uncomplicated upper respiratory tract viral infection symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache.
4)Inclusion of symptomatic patients.
|
|
| ExclusionCriteria |
| Details |
1) Unwilling for participation.
2) Physical and mental disability.
3) Medical restriction for physical movement.
4) History of recent surgery.
5) Patients with Pneumonia, Acute Respiratory Distress Syndrome (ARDS) & patients admitted in Intensive Care Units (ICU).
6) Pregnant females.
7) Patients with severe co-morbid conditions (Congestive Heart failure, Uncontrolled Diabetes, Renal failure on hemodialysis, Cancer patients). |
|
|
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 5th and Day 6th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stress, Anxiety and Mindfulness |
Day 5th and Day 6th
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
11/01/2021 |
| 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 patients with symptoms. |