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CTRI Number  CTRI/2020/06/026103 [Registered on: 24/06/2020] Trial Registered Prospectively
Last Modified On: 23/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   Clinical trial of an Ayurveda Intervention 
Scientific Title of Study
Modification(s)  
Evaluation Of The Immuno-Stimulatory Potential (Shareera Bala) Of An Ayurveda Management Protocol In Cohort Of Dda Resident Of Gautampuri - An Exploratory Clinical Study 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vittal Huddar 
Address  Room no 621, 6th floor academic block, department of Kayachikitsa, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, NEW DELHI-110076

New Delhi
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  dr.vghuddar@aiia.gov.in  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Vittal Huddar  
Address  Room no 621, 6th floor academic block, department of kayachikitsa, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, NEW DELHI-110076

New Delhi
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  dr.vghuddar@aiia.gov.in  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Vittal Huddar 
Address  Room no 621, 6th floor academic block, department of kayachikitsa, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, NEW DELHI-110076

New Delhi
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  dr.vghuddar@aiia.gov.in  
 
Source of Monetary or Material Support
Modification(s)  
ALL INDIA INSTITUTE OF AYURVEDA, Gautampuri, Sarita Vihaar, Mathura road, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  ALL INDIA INSTITUTE OF AYURVEDA, Mathura road, Gautampuri, Sarita Vihar, New Delhi 110076  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr vittal Huddar  All India Institute of Ayurveda  opd 1, ground floor,hospital block, All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi
New Delhi
 
9986697942

dr.vghuddar@aiia.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of All India Institute of Ayurveda New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional medicine preventive guidelines  Only following conventional medicine preventive guidelines 
Intervention  Samshamani Vati 500 mg bid   Samshamani Vati 500 mg bid after food with water for 8 weeks 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.DDA residents, Gautampuri of either sex aged 19-60 years
2.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.
3.Individuals agree to give consent for participation
 
 
ExclusionCriteria 
Details  1.Individuals with chronic comorbid conditions which has affected the Bala of the Individual.
2.Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results
3.Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19
4.Previously diagnosed with COVID-19
5.Subjects on other prophylactic medications.
6.Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1.Improvement in Bala of an individual
2.Immuno-stimulation leading to non-development of symptoms of CoVID-19 in risk population exposed to infected individuals.
 
Baseline, After 30, 60 and 90 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of life(Sf-36 proforma will be used)   4 week 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   09/07/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Brief Summary  

As there does not exist a definitive treatment for the viral infection in the conventional medicine till now, the symptomatic management and empirical line of management considered as the standard line of care. Preventive medicine being the core objective of Ayurveda by maintaining health of a healthy individual by following Dinacharya, Rutuchary and Consuming Rasayana, one can prevent from being affected by disease in future. In this situation of outbreak of COVID-19, taking care of warriors involved in the battle of defeating COVID -19 outbreak, it becomes logical to prevent them by employing the Ayurveda principles in prevention of diseases as mentioned above. Here is an attempt to intervene the general public to follow the guidelines of AYUSH ministry in preventing from becoming infected with COVID-19.

 

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