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CTRI Number  CTRI/2020/06/025714 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 31/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Holistic Health Management through Yoga and Naturopathy for Frontline COVID Health Care Providers – The H2M trial 
Scientific Title of Study   Holistic Health Management through Yoga and Naturopathy for Frontline COVID Health Care Providers – The H2M trial 
Trial Acronym  The H2M Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manavalan Narayanaswamy 
Designation  Principal 
Affiliation  Government Yoga AND Naturopathy Medical College 
Address  Department of Naturopathy, Government Yoga & Naturopathy Medical College, Arignar Anna Indian Medicine Campus Arumbakkam, Chennai Chennai TAMIL NADU 600106 India

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  gynmcchennai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manavalan Narayanaswamy 
Designation  Principal 
Affiliation  Government Yoga AND Naturopathy Medical College 
Address  Department of Naturopathy, Government Yoga & Naturopathy Medical College, Arignar Anna Indian Medicine Campus Arumbakkam, Chennai Chennai TAMIL NADU 600106 India


TAMIL NADU
600106
India 
Phone    
Fax    
Email  gynmcchennai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manavalan Narayanaswamy 
Designation  Principal 
Affiliation  Government Yoga AND Naturopathy Medical College 
Address  Department of Naturopathy, Government Yoga & Naturopathy Medical College, Arignar Anna Indian Medicine Campus Arumbakkam, Chennai Chennai TAMIL NADU 600106 India


TAMIL NADU
600106
India 
Phone    
Fax    
Email  gynmcchennai@gmail.com  
 
Source of Monetary or Material Support  
Indian Naturopathy And Yoga Graduates Medical Association, 119, parasurama Easwaran Kovil North Mada Street, Ayanavaram, Chennai-600023 
 
Primary Sponsor  
Name  Government Yoga And Naturopathy Medical College and Hospital Chennai 
Address  Arumbakkam, Chennai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narayana Babu  Government Medical College Omandurar estate  Department of Medicine, Omandurar Medical College Hospital, Chennai Chennai TAMIL NADU
Chennai
TAMIL NADU 
04425333317

gmcomandurar@gmail.com 
Dr N Manavalan  Government Yoga & Naturopathy Medical Collge & Hospital  Department of Naturopathy, Government Yoga & Naturopathy Medical College & Hospital, Arignar Anna Indian Medicine Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU 
9840128684

gynmcchennai@gmail.com 
Dr B Balaji  Stanley Medical College Hospital  Department of Medicine, Stanley Medical College, Chennai Chennai TAMIL NADU
Chennai
TAMIL NADU 
04425282350

stanleyhospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, GYNMC, Chennai  Approved 
Institutional Ethics Committee, Omandurar Medical Collge, chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Doctors and healthcare workers working in COVID19 prevention and clinical wards 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Usual care  Usual care / No intervention 
Intervention  Yoga & Naturopathy  1. Prevalidated scientific yoga module comprising of asanas, pranayama, relaxation and meditation would be administered by a Government Yoga and Naturopathy physician for 6 days a week for 4 weeks as a recorded video. 2. A set of 5 simple lifestyle modification tips would be recommended to be followed by the participants in the a. Drinking 1.5 – 2 litres of water everyday b. Practicing mental silence for 10 minutes everyday c. Diet to include sprouts, greens and vegetables daily and Making one meal a complete fruit diet atleast once a week d. Hot water with salt and turmeric gargling once a day e. Including natural immune boosting fresh juice (made of Indian Gooseberry, Ginger, Turmeric,tulsi and lemon) and natural immune boosting hot drink (made of ginger, tulsi, pepper, liquorice, turmeric) once a day.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Doctors and healthcare workers of all ages irrespective of gender
2. Willingness to participate
 
 
ExclusionCriteria 
Details  Confirmed diagnosis of COVID-19
Explicit non-willingness to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Perseverative Thinking Questionnaire
2. GAD7 Questionnaire
3. Pittsburg Sleep Quality Index
4. Freiburg Mindfulness Inventory
5. Qualitative assessments for Subjective perception of Stress and Yoga 
15 days and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
2. GAD7 Questionnaire
3. Pittsburg Sleep Quality Index
4. Freiburg Mindfulness Inventory
5. Qualitative assessments for Subjective perception of Stress and Yoga 
15 days and 4 weeks 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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 3/ Phase 4 
Date of First Enrollment (India)   02/06/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Brief Summary   As there is no convincing evidence regarding the best strategy to promote mental wellbeing in the COVID19 crisis, we propose to implement Yoga and Naturopathic intervention to the frontline health workers on an in-person / virtual platform to assess its health benefits. 
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