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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 Trial 
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.

 

 

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