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CTRI Number  CTRI/2020/05/025320 [Registered on: 22/05/2020] Trial Registered Prospectively
Last Modified On: 22/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Yoga & Naturopathy in patients with COVID-19 
Scientific Title of Study   NATUROPATHY AND YOGA IN THE MANAGEMENT OF COVID19 A Multi-center controlled clinical trial 
Trial Acronym  YONAC Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  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 
Phone    
Fax    
Email  gynmcchennai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manavalan Narayanaswamy  
Designation  Principal 
Affiliation  Government Yoga AND Naturopathy Medical College 
Address  Arumbakkam, Chennai


TAMIL NADU
600106
India 
Phone    
Fax    
Email  gynmcchennai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  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 
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 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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P Vasanthamani  Kilpauk Medical College Hospital  Department of Medicine, Kilpauk Medical College, Chennai
Chennai
TAMIL NADU 
04426412979

dean@gkmc.in 
Dr Narayana Babu  Omandurar Medical College Hospital  Department of Medicine, Omandurar Medical College Hospital, Chennai
Chennai
TAMIL NADU 
04425333317

gmcomandurar@gmail.com 
Dr Jayanthi  Rajiv Gandhi General Hospital Chennai  Department of Medicine, 044 Rajiv Gandhi General Hospital Chennai
Chennai
TAMIL NADU 
04425305000

deanmmc@tn.gov.in 
Dr B Balaji  Stanley Medical College Hospital  Department of Medicine, Stanley Medical College, Chennai
Chennai
TAMIL NADU 
04425282350

Stanleyhospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Government Yoga And Naturopathy Medical College  Approved 
IEC, Kilpauk Medical College, Chennai  Submittted/Under Review 
IEC, Madras Medical College, Chennai  Submittted/Under Review 
IEC, Stanley Medical Collge, 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 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Care  Standard care as per local protocol 
Intervention  Yoga & Naturopathy immune boostinng and stress management protocol  Essential: 1. Natural immune boosting fresh juice: Indian Gooseberry juice – 50ml Basil Juice – 50ml Ginger Juice – 10ml Fresh Lime juice – 5ml Turmeric powder – ¼ tsp Water – 150 ml (Morning) 2. Natural immune boosting hot drink: Peeled Crushed Ginger 5 gm, Tulsi (Basil) leaves 10 gms, Pepper powder ¼ tsp, Crushed Adhimaduram 5 gms (liquorice root), Turmeric powder ¼ tsp and drinking water 250 ml (Evening). 3. Yoga: Vajrasana, Bhastrika, Brahmari, Quick relaxation technique, Deep relaxation technique, Jala Neti (twice/thrice a day) Care as indicated by Y&N physician 1. Hot water gargling: Taking 30-50 ml of water and whirl it around pharynx & oral cavity. 2. Steam inhalation: Inhalation of steam with or without essential oils for 5-10 minutes. 3. Sun bath: Sun exposure (10 minutes) in the morning and in the evening 4. Aromatherapy (Eucalyptus/peppermint/thyme/lavendar/basil): 1-2 drops in tissue paper or mix with gingely oil & apply over nose and neck. These treatments will be given from enrollment till 14 days post-confirmation of infection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or their family members will be obtained wherever applicable.
b) Male or Female adult patient ≥18 years and ≤75 years of age at the time of recruitment
c) Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen
d) Asymptomatic / uncomplicated illness / mild pneumonia COVID-19 as defined by ICMR
 
 
ExclusionCriteria 
Details  a) Explicit non-willingness to be a part of the research study
b) Patients with moderate/severe stages of COVID19
c) Participation in any other clinical trials
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to progress to next stage of severity i.e., from asymptomatic/uncomplicated/mild pneumonia to moderate/severe stages  At 15 days  
 
Secondary Outcome  
Outcome  TimePoints 
Clinical endpoints
1. Time to All-cause mortality at discharge
2. All-cause mortality at 28 days
Measures of morbidity
1. Number of days lived with infection
2. Number of days lived with intensive care if the disease has progressed to severe infection from asymptomatic, mild, and moderate stages.
3. Measuring the symptoms using standard scores
Patient reported outcome
1. Quality of life as assessed by WHO-QoL BREF
2. Anxiety as assessed by GAD scale
Safety outcomes 
At Discharge 
 
Target Sample Size   Total Sample Size="658"
Sample Size from India="658" 
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)   22/05/2020 
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)  Open to Recruitment 
Publication Details   Nil 
Brief Summary   YONAC trial is a multi-centre controlled trial aimed at improving outcomes in patients diagnosed with COVDI19 with Yoga & Naturopathy treatment modalities which includes a natural immune boosting fresh juice (, natural immune boosting hot drink and Yoga. In addition, based on the need, hot water gargling, steam inhalation, essential oil (eucalyptus/peppermint/thyme/lavendar/basil), self acupressure will be provided to the patients. 
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