CTRI Number	CTRI/2020/06/026103 [Registered on: 24/06/2020] Trial Registered Prospectively
Last Modified On:	13/04/2021
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) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Closed to Recruitment of Participants
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.