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CTRI Number  CTRI/2020/05/025493 [Registered on: 31/05/2020] Trial Registered Prospectively
Last Modified On: 30/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of Ayurvedic medicine in the Prophylaxis for COVID-19 of Police personnel Dept of AYUSH, TS & CCRAS- NIIMH, Hyderabad. 
Scientific Title of Study   Prospective Open label Observational study on the Effect of Chyawanprash, Samshamani vati & Haritaki (Raksha Kit) as Prophylactic measure among police personnel working in the vicinity of COVID -19 facilities 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madikonda Praveen kumar 
Designation  Assoc. Professor, Department of Panchakarma  
Affiliation  Dr. B.R.K.R. Government Ayurvedic College 
Address  Department of Panchakarma, Dr. B.R.K.R. Government Ayurvedic College SR Nagar Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madikonda Praveen kumar 
Designation  Assoc. Professor, Department of Panchakarma  
Affiliation  Dr. B.R.K.R. Government Ayurvedic College 
Address  Department of Panchakarma, Dr. B.R.K.R. Government Ayurvedic College SR Nagar Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madikonda Praveen kumar 
Designation  Assoc. Professor, Department of Panchakarma  
Affiliation  Dr. B.R.K.R. Government Ayurvedic College 
Address  Department of Panchakarma, Dr. B.R.K.R. Government Ayurvedic College SR Nagar Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Source of Monetary or Material Support  
Department of AYUSH Govt. of Telangana– Ayurveda & CCRAS-NIIMH, Hyderabad  
 
Primary Sponsor  
Name  Department of AYUSH Govt of Telangana Ayurveda CCRASNIIMH Hyderabad 
Address  Department of Ayush, Opposite passport office, Government Of Telangana 
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 
Madikonda Praveen kumar   Dr BRKR Government Ayurvedic College  Department of Panchakarma, Room number 2 & 5, SR Nagar
Hyderabad
TELANGANA 
9849271601

pkmadikonda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee CCRAS-NIIMH, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  police personnel working in the vicinity of Covid 19 Facilitites  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  68.00 Year(s)
Gender  Both 
Details  2. Police personnel working within the facilities of COVID-19 duties.
3. Subjects who are from a community where at least 1 confirmed case is already identified.
4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
 
 
ExclusionCriteria 
Details  1. Pregnant and Lactating females.
2. Known cases of uncontrolled Diabetes and Hypertension.
3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention.
8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparative assessment of occurrence of COVID-19 infection in healthy volunteers vis Police personal in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
General health status of those who are taking Ayurveda preventive medicine.
 
3 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2020 
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 
Brief Summary   in view of the  no treatment available for COVID-19 infection as on date, there is a need to investigate the potential of ayurvedic preventive medicine.  Classical texts of Ayurveda have emphasized the out break of such pandemics in the name of "Janapadodhwamsa"  and  narrated  a specific preventive protocol. This is an attempt to observe the preventiive role of Ayurveda protocol in police personel / Healthy volunteers working in the vicinity of covid-19 facilities.  
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