CTRI Number	CTRI/2020/05/025178 [Registered on: 14/05/2020] Trial Registered Prospectively
Last Modified On:	13/05/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda Preventive
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Evaluation of the Immuno-Stimulatory Potential (Shareera Bala) of an Ayurveda Management Protocol in Cohort of Quarantined Delhi Police under Covid-19 Care Centers- An Exploratory Clinical Study
Scientific Title of Study Modification(s)	Evaluation of the Immuno- stimulatory Potential (Shareera Bala) of an Ayurveda management protocol in Cohort of Quarantined Delhi police under Covid-19 care centers- 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  PIprof Dr Tanuja Nesari   Address  7th floor, room no 716, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 7th floor, room no 716, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi New Delhi DELHI 110076 India  Phone  8849802005   Fax     Email  director@aiia.gov.in
Details Contact Person Scientific Query Modification(s)	Name  Dr VG Huddar  Address  6th floor, room no 610,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi New Delhi DELHI 110076 India  Phone  9986697942   Fax     Email  dr.vghuddar@aiia.gov.in
Details Contact Person Public Query	Name  Dr VG Huddar  Address  6th floor, room no 610,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 6th floor, room no 610,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi DELHI 110076 India  Phone  9986697942   Fax     Email  dr.vghuddar@aiia.gov.in
Source of Monetary or Material Support	All India Institute of Ayurveda
Primary Sponsor	Name  All India Institute of Ayurveda  Address  All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Mahesh Vyas  All India Institute of Ayurveda  OPD no 1, All India Institute Of Ayurveda Hospital Block, Gautampuri, Sarita Vihar, New Delhi New Delhi   8849802005 dr.maheshvyas@aiia.gov.in
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  the 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 Modification(s)	Type  Name  Details  Intervention  group-A  1. TabSamshamani Vati 250 mg 2 bid after food with water for 60 days 2. Herbal tea – 150 ml in the morning once daily for 60 days( Preparation of Herbal tea: Boil 150 ml (1 glass) of water, at the time of boiling add 1 small tsf (3gms) of powder boil for 1-2 minutes. Switch off the stove and keep the lid for 1-2 mins till it settles and this herbal tea is ready to drink warm after filtering) 3. Application of Anu taila This oil is to be applied locally inside both the nostrils. This is to be applied in the morning before b and before leaving home and before retiring to bed. 4. Haridra khanda , 3gms bid with milk before food. (if sore throat, cold, cough seen)  Comparator Agent  group-B  conventional medicine preventive guidelines
Inclusion Criteria	Age From  19.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1.Available police personnel of either sex aged 19-60 years 2.Delhi Police personnel quarantined for COVID-19 infection. 3.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. 4.Individuals agree to give consent for participation
ExclusionCriteria	Details  1.Individuals with uncontrolled co morbid conditions which may affect 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	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Improvement in Bala of an individual Immuno-stimulation leading to non-development of symptoms of CoVID-19 in risk population exposed to infected individuals. (Bala will be assessed by using specialised proforma including dashavidha pareeksha and other questionnaires which will reveal the physical and mental health of an individual.)  Baseline, 15th day, 30th day, 45th day, 60th day and 90th day
Secondary Outcome Modification(s)	Outcome  TimePoints  Improvement in quality of life( SF-36 per forma will be used)   12 week
Target Sample Size	Total Sample Size="140" Sample Size from India="140"
Phase of Trial	Phase 2
Date of First Enrollment (India)	18/05/2020
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	There is no particular treatment for Covid-19 yet. Preventive medicine being the core objective of Ayurveda by maintaining health of a healthy individual by following Dinacharya, Rutuchary and Consuming Rasayana, one can prevented from the affected by disease in future.