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CTRI Number  CTRI/2020/07/026925 [Registered on: 30/07/2020] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   to see the effect of twakadi(tea made up of dalcheeni, tulasi pepper, clove, etc)tea on police worker who have a duty in covid 19 pandemic 
Scientific Title of Study   Clinical trials to evaluate prophylactic action of Twakadi herbal tea in police professionals working in COVID19 pandemic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogini Kulkarni 
Designation  Professor 
Affiliation  carc akurdi 
Address  Department of Research college of Ayurved and Research Center, Akurdi
ground floor, shalyatantra department, ayurved rugnalay and sterling multispeciality hospital, nigdi pradhikaran, sector 26 near bhel chowk pune 411044
Pune
MAHARASHTRA
dr Yogini Kulkarni
India 
Phone  9822419089  
Fax    
Email  dryoginik01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogini Kulkarni 
Designation  Professor 
Affiliation  CARC Akurdi 
Address  Department of Research College of Ayurved and Researche center, Akurdi

Pune
MAHARASHTRA
dr Yogini Kulkarni
India 
Phone  9822419089  
Fax    
Email  dryoginik01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yogini Kulkarni 
Designation  Professor 
Affiliation  carc akurdi 
Address  Department of research College Of Ayurved and Research center Akurdi

Pune
MAHARASHTRA
dr Yogini Kulkarni
India 
Phone  09822419089  
Fax    
Email  dryoginik01@gmail.com  
 
Source of Monetary or Material Support  
Sterling Multispeciality Hospital and Ayurved Rugnalay 
 
Primary Sponsor  
Name  Sterling Multispeciality Hosptal and Ayurved Rugnalay 
Address  Sector 27 Nigdi Pradhikaran near Bhel chowk Nigdi Pune 411044 
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  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogini Kulkarni  Sterling Multispeciality Hospital and Ayurved Rugnalay  Ground floor, Shalyatantra Department, Ayurved Rugnalay and Sterling Multispeciality Hospital, Nigdi Pradhikaran, sector 26 near Bhel Chowk pune 411044
Pune
MAHARASHTRA 
9822419089

dryoginik01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical comitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Police professionals having age above 25 irrespective of gender 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Twakadi herbal tea  procurement of all herbs(tulasi, Pippali, yashtimadhu, Ginger, Draksha, Dalchini) from authentic sources,(1 cup) authentication of herbs by botanical institutes, standarization of all course powder as per API analysis, tea bag preparation 
Comparator Agent  use of mask social distancing.   preventive measures regarding covid 19 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  police professionals working in covid 19 pandemic having age above 25 years irrespective of gender.
negative for covid 19.
who are willing to provide signed informed consent  
 
ExclusionCriteria 
Details  pregnant ladies 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number Of Participants With Laboratory Confirmed COVID-19 positivity in 14 days  Number of participants with laboratory confirmed COVID-19 positivity in 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
inflammatory markers (CRP) at the end of the baseline and end of the treatment.
ADR/AE recorded
number of partcipants who suffered with any type of infective disease during the trial period 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   31/07/2020 
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   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Indicating overall aims of the research importance of the objectives and their application in the context of the priority area set out in the application form.
As per ayurveda it is mentioned that those who have some doshvaigunya or suffered with other diseases as diabetes, heart diseases, and hypertension are more prone to viral infectious diseases. so this  study  is aimed at to compare the incidence of covid 19 pandemic between the test and control group. So the prophlactic action of twakadi herbal tea in police professionals who are having age more than 25 yeara will be evalueted by the incidence of the disease. If the individuals get positive for covid 19 if any of group will be evalueted for severity of the symptoms.   
 
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