| 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
|
|
|
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
|
|
|
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 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |