| CTRI Number |
CTRI/2021/05/033816 [Registered on: 27/05/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Yoga & naturopathy-based telemedicine as an adjuvant therapy in improving quality of life and alleviating anxiety and depression in mild to moderate COVID-19 positive patients |
|
Scientific Title of Study
|
Yoga & naturopathy-based telemedicine as an adjuvant therapy in improving quality of life and alleviating anxiety and depression in mild to moderate COVID-19 patients who are in home quarantine. A non-randomized control trial |
| Trial Acronym |
YONAC-19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head, Research |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Department of Research
Room No 9
Yoga and Naturopathy Division
Sant Hirdaram Nagar
Bhopal 460320
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
director@iaswar.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head, Research |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Department of Research
Room no 9
Yoga and Naturopathy Division
Sant Hirdaram Nagar
Bhopal 462030
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
director@iaswar.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep MK Nair |
| Designation |
Professor and Head, Research |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Department of Research
Room no 9
Yoga and Naturopathy Division
Sant Hirdaram Nagar
Bhopal 462030
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
director@iaswar.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Sant Hirdaram Nagar
Bhopal
Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Pradeep MK Nair |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women Bhopal |
| Type of Sponsor |
Other [Individual initiated study] |
|
|
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 |
| Gulab Rai Tewani |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for women, Bhopal |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Arogya Kendra, sant Hirdaram yoga and naturopathy Hospital,
Room no 1
Sant Hirdaram Nagar
Bhopal 462030
Bhopal
MADHYA PRADESH |
7000915602
drgulabtewani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SHMCNYS |
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 |
Standard of care with Meditation |
Patients will be doing meditation practice along with standard of care prescribed by conventional physicians as per ICMR norms. The meditation practice will be given 15 minutes daily for 14 days. |
| Intervention |
Yoga and naturopathy Home remedies |
Yogasanas:
1. Hand in and out breathing 5 rounds – 1 minute
2. Hand stretch breathing – 10 rounds 2 mins
3. Skanda chalasana ( shoulder rotation) – 5 rounds – 3 minutes
4. Gomukhasana – 1 round 1 minute
5. Makarasana – 1 minute 1 round. (note: if there is any difficulty in breathing, change to a comfortable posture immediately)
Pranayama:
1. Vibhagiya pranayama- 5 rounds – 3minutes
2. Nadishuddhi – 10 -15 rounds (internal breath retention for 5 seconds)
3. Bhramari pranayama – 10 -15 rounds ( Note: U can do it according to your capacity. DO NOT STRAIN, but repeat it after sometime)
4. Guided meditation or deep relaxation technique (YouTube link will be sent). Do it in a comfortable posture.
Naturopathy Diet:
1. Easily digestible food. (vegetable soups, khichdi, jowar/ bajra/ red rice/ single polished rice with boiled vegetable with added mild spices – jeera,dhania powder, hing, ginger, garlic ( crushed 1 pod), chat masala, black pepper (1 pinch), jaljeera with luke warm water after food.
2. Saunf - less than ¼ tsp after food ( 3times a day)
3. Ajwain ka kadha - 150ml of water + 1/4 tsp of ajwain + jaggery 1/4 tsp - boil it on low flame for 10mins. Consume it 100ml 1/2 an hour before food. ( 3 times a day)
4. Steam inhalation – 2 drops of eucalyptus oil and ajwain 1 pinch – 2 – 3 times per day
5. Apply eucalyptus oil on the back and chest region before going to bed. And inhale the same fragrance for 5 minutes.
6. Acupressure
In addition to this the patients will be continuing with their standard of care interventions as per ICMR protocols. The total duration of yoga therapy will be for 45 mins daily for 14 days. Other dietary advises will be given one time at the baseline as a part of daily routine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All positive mild and moderate COVID-19 cases who are receiving standard care and are in home quarantine.
Patients willing to consent to participate in the study |
|
| ExclusionCriteria |
| Details |
All positive mild and moderate COVID-19 cases who are in hospital care
Patients who require supplemental oxygen therapy
Pregnant and lactating mothers
Patients who are under 18 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety and depression assessed by DASS 21 scale, improvement in QOL assessed by WHO-Bref, Improvement in symptoms |
At baseline Baseline
Anxiety and depression assessed by DASS 21 scale, Quality of Life assessed by WHO-BREF
At 14th Day from baseline
Anxiety and depression assessed by DASS 21 scale, Quality of Life assessed by WHO-BREF |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms |
Baseline and daily till 14 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/05/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [director@iaswar.com].
- For how long will this data be available start date provided 18-09-2021 and end date provided 18-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
COVID-19 has induced a lot of distress across the nation. Medical
fraternities of different disciplines are putting their best foot forward to combat this deadly virus.
Yoga & Naturopathy is an evidence based system of medicine that can complement the
conventional care in bringing better results. The outcome of this research will facilitate in
helping many more patients across the globe that these interventions are beneficial. the patients will recieve either yoga and naturopathy based lifestyle modification or meditation in addition to the standard of care. We will be evaluating the changes in QOL and anxiety and depression along with symptom score in mild to moderate covid 19 positive patients who are in home quarantine. |