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CTRI Number  CTRI/2020/05/025171 [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   Ayurveda protocol & COVID-19 exposed individuals: Clinical trial of an Ayurveda Intervention  
Scientific Title of Study
Modification(s)  
Evaluation of the Immuno-stimulatory(Shareera Bala) potential of Ayurveda management protocol in Cohort of Delhi Police - 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  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  
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 Volunteer both gender 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  group A -Tab Samshamani Vati 2.Anu taila 3.rock salt and turmeric duration 4.Ayush preventive guidelines   1.Tab Samshamani Vati 250 mg 2 bid after food with water 2.Application of Anu taila 2 drops each nostrils once a day after bath in the morning 3.Gargle with warm water mixed with rock salt and turmeric 4.Ayush preventive guidelines for COVID 19 with Yoga and Pranayama- for 8 week  
Comparator Agent  Group B  Conventional preventive medicine 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.All Delhi Police personnel having risk of exposure to 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 chronic co morbid 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   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 specialized proforma including dasvidha pareeksha and other questionnaires which will revel the physical and mental health of an individuals) 
8 week
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Improvement in quality of life (SF-36 proforma will be used)   12 week 
 
Target Sample Size   Total Sample Size="50000"
Sample Size from India="50000" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/05/2020 
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 are no exact treatment guidlines for covid-19.  Preventive medicine being the core objective of Ayurveda by maintaining health of a healthy individual by following Dinacharya, Rutuchary and Consuming Rasayana, one can be  prevented from the disease in future.  

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