CTRI Number	CTRI/2020/05/025430 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On:	28/05/2020
Post Graduate Thesis	No
Type of Trial	Observational
Type of Study	Cross Sectional Study
Study Design	Single Arm Study
Public Title of Study Modification(s)	EFFECT OF AYURVEDA IMMUNO-MODULATOR DRUGS on HEALTH OF CORONA WARRIORS
Scientific Title of Study Modification(s)	A Cross Sectional Study To Observe The Health Status Of Personnels Engaged In Care Of Covid-19 Infected/Suspected Persons And Receiving Ayurveda Immuno-Modulator Drugs In Jodhpur City
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Prem Prakash Vyas  Address  Room no 155 University College of Ayurved Dr S R Rajasthan Ayurved University Nagour Road, Karwar, Jodhpur, Rajasthan Nagour Road, Karwar, Jodhpur, Rajasthan Jodhpur RAJASTHAN 342037 India  Phone  9414351871   Fax     Email  drppvyas@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Prem Prakash Vyas  Address  Room no 155 University College of Ayurved Dr S R Rajasthan Ayurved University Nagour Road, Karwar, Jodhpur, Rajasthan Nagour Road, Karwar, Jodhpur, Rajasthan Jodhpur RAJASTHAN 342037 India  Phone  9414351871   Fax     Email  drppvyas@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Prem Prakash Vyas  Address  Room no 155 University College of Ayurved Dr S R Rajasthan Ayurved University Nagour Road, Karwar, Jodhpur, Rajasthan Nagour Road, Karwar, Jodhpur, Rajasthan Jodhpur RAJASTHAN 342005 India  Phone  9414351871   Fax     Email  drppvyas@gmail.com
Source of Monetary or Material Support Modification(s)	Dr S R Rajasthan Ayurved University Nagour Road, Karwar, Jodhpur, Rajasthan
Primary Sponsor Modification(s)	Name  Dabur India Ltd  Address  Delhi  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Prem Prakash Vyas  Dr S R Rajasthan Ayurved University  Nagour Road, Karwar, Jodhpur, Rajasthan Jodhpur   9414351871 drppvyas@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee Uca Dsrrau Jodhpur  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Healthy personnel’s engaged in care of covid-19 infected/suspected persons
Intervention / Comparator Agent	Type  Name  Details
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  65.00 Year(s) Gender  Both  Details  Person deployed in quarentine ward Person on hard duty family members of health care personnel willingness to participate in study Taking Ayurveda immunomodulator drugs ( Tab. Maha Sudarshan vati + Tab Samshamani Vati + Tab. Haridra
ExclusionCriteria	Details  Person below 18 yrs & above 65 yrs Preganant women Any medical condition for which the person is recieing any immunosupressive medicine Known case of malignancy
Method of Generating Random Sequence	Adaptive randomization, such as minimization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  To boost immunity of engaged person in care of COVID-19 infected/ suscpected cases  15 days
Secondary Outcome	Outcome  TimePoints  To maintain healthy status of engaged person in care of COVID-19 infected/ suscpected cases-15 days  15 DAYS
Target Sample Size	Total Sample Size="1000" Sample Size from India="1000"
Phase of Trial	Phase 1
Date of First Enrollment (India)	03/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="0" Days="30"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	Nil
Brief Summary	On 12 January 2020, the World Health Organization (WHO) confirmed that a novel coronavirus was the cause of a respiratory illness in a cluster of people in Wuhan City, Hubei Province, China, which was reported to the WHO on 31 December 2019. On 30 January, India reported its first case of COVID-19 in Kerala. The transmission escalated during March, after several cases were reported all over the country, most of which were linked to people with a travel history to affected countries. On 24 March, PM announced a complete nationwide lockdown, starting from midnight for 21 days.   In Rajasthan, on 2 March 2020, an Italian tourist who was part of a group of 23 tourists from Italy tested positive for COVID-19. The first case in Jodhpur was reported in second week of March, 2020 Jodhpur with a population of 9.21 lakh. Local administration worked very efficiently and established several Quarantine Centres in the city to admit all the suspected contacts of confirmed cases. A big number of Medical including AYUSH doctors, para-medical, housekeeping, security/ police staff and other supporting staff are serving continuously and are having great risk of infection. However, susceptibility of infection is much concerned with individual immunity status. A person with good immunity is likely to be affected less.   Ministry of AYUSH, Govt of India has issued an Advisory and suggested various measures including use of certain Ayurvedic medicines which are quite effective to modulate the immune system to keep the status of immunity at optimum level. On demand of local administration, the University has arranged such drugs for those personals and they started using them as per directions of concerned experts. Taking this opportunity in action, a research group formed through Centre for Innovation & Research Network, DSRR Ayurved University, Jodhpur, has planned to conduct a cross-sectional study to observe that whether the persons taking Ayurveda immune-modulators are having any impact on their health status.