CTRI Number	CTRI/2020/05/025171 [Registered on: 14/05/2020] Trial Registered Prospectively
Last Modified On:	04/02/2022
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda Preventive
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Ayurveda intervention as Prophylactic trial against COVID-19
Scientific Title of Study Modification(s)	Prophylactic potential of “AYURAKSHA” kit to boost immunity against COVID-19 among frontline Delhi police personals: A Non-randomized controlled intervention trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Prof 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	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 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 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 Modification(s)	Name  Address  All India Institute of Ayurveda  All India Institute of Ayurveda
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Mahesh Vyas  All India Institute of Ayurveda  OPD no 7,All India Institute of Ayurveda Hospital Block, Gautampuri, Sarita Vihar, New Delhi New Delhi   8849802005 dr.maheshvyas@aiia.gov.in
Details of Ethics Committee Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  the institutional ethics committee of All India Institute of Ayurveda, New Delhi  Approved  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 Volunteer both gender
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Group A Trial group Intervention will be given for a period of 08 weeks   1.Tab Samshamani Vati 500 mg BD 2.Application of Anu taila two drops in each nostrils twice a day 3.Ayush preventive guidelines for COVID 19   Comparator Agent  Group B Control group   Only AYUSH preventive guidelines for COVID-19 will be given
Inclusion Criteria Modification(s)	Age From  19.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1.Either sex aged 19-60 years 2.Who are on duty in different units and districts of Delhi state. 3.Who agrees to give consent for participation and 4.Who agrees not to take any other prophylactic medicines during the trial period.
ExclusionCriteria	Details  1.Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results 2.Those who will be infected with COVID-19 recently within 1 month 3. Individuals found positive for IgG COVID-19 4. Subjects on other prophylactic medications
Method of Generating Random Sequence Modification(s)	Not Applicable
Method of Concealment Modification(s)	Not Applicable
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  1. Change in immune status score using ISQ, will be assessed at baseline (day 0), after 60days of intervention 2. Change in IgG COVID-19 Positivity by COVID specific IgG.   baseline (day 0), and after 60days
Secondary Outcome Modification(s)	Outcome  TimePoints  Improvement in quality of life (SF-36 proforma will be used)   12 week
Target Sample Size Modification(s)	Total Sample Size="68" Sample Size from India="68"
Phase of Trial	Phase 2
Date of First Enrollment (India) Modification(s)	19/05/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial Modification(s)	Years="0" Months="2" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	under process
Brief Summary Modification(s)	There are no exact treatment for COVID-19.  Prevention is the core objective of Ayurveda which maintains health of a healthy individual. The Delhi police personnel (front line warriors of Capital territory region, New Delhi, India)  involved in managing discipline and lockdown across the country during the first wave of COVID-19 will be provided with  “AYURAKSHA” kits by the All-India Institute of Ayurveda (AIIA) under the guidance of Ministry of AYUSH as prophylaxis to enhance their immunity status. The “AYURAKSHA” kit contains Sanshamani Vati (prepared from Tinospora cordifolia), AYUSH Kadha and Anu Taila for nasal application). The study will determine the efficacy of Ayurveda intervention in terms of post-interventional IgG COVID-19 Positivity, improving immunity levels, quality of life (QoL) against COVID-19, and changes in their respective haematological and biochemical parameters among trial group as compared to control group participants.