FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Tanuja Nesari  
Designation  Director  
Affiliation  All India Institute Of Ayurveda 
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 of Contact Person
Scientific Query
 
Name  Dr VG Huddar 
Designation  Associate Professor 
Affiliation  All India Institute Of Ayurveda 
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 of Contact Person
Public Query
 
Name  Dr VG Huddar 
Designation  Associate Professor 
Affiliation  All India Institute Of Ayurveda 
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  
Name  Address 
All India Institute of Ayurveda  All India Institute of Ayurveda 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  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
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  
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" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
19/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.


 
Close