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CTRI Number  CTRI/2020/06/025761 [Registered on: 09/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Population based cross sectional study for COVID 19 prophylaxis with Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non containment zones during 2020 pandemic in Tamil Nadu, South India 
Scientific Title of Study   Population based cross sectional study for COVID 19 prophylaxis with Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non containment zones during 2020 pandemic in Tamil Nadu, South India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Meenakumari 
Designation  Director 
Affiliation  National institute of Siddha  
Address  National institute of siddha tambaram sanatorium
National institute of siddha tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9176534465  
Fax    
Email  nischennaisiddha@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr G J Christian  
Designation  Head of the Department , department of Noi Naadal 
Affiliation  National institute of Siddha 
Address  national institute of siddha tambaram sanatorium
national institute of siddha tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G J Christian  
Designation  Head of the Department , department of Noi Naadal 
Affiliation  National institute of Siddha 
Address  national institute of siddha tambaram sanatorium
national institute of siddha tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
National institute of Siddha, Tmbaram Sanatorium, chennai - 47.  
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National institute of Siddha, Tambaram Sanatorium, Chennai - 47 
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 
Christian G J  Tambaram Taluk  Mudichur, Rajakilpakkam, Hastinapuram, Pammal , Tambaram
Kancheepuram
TAMIL NADU 
9962545930

christianvijila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instuitional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  COVID Prophylaxis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) Laboratory confirmed COVID-19 with or without symptoms
b) Those who are to be excluded in the study, as evaluated by the investigators.
c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP
certified pharma companies.
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d) Persons with poor drug compliance 
 
ExclusionCriteria 
Details  a) Laboratory confirmed COVID-19 with or without symptoms
b) Those who are to be excluded in the study, as evaluated by the investigators.
c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP
certified pharma companies.
7
d) Persons with poor drug compliance 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
COVID-19 Test Positivity / Negativity upto 31 days follow up.  COVID-19 Test Positivity / Negativity upto 31 days follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
General and specific health status as described above.
Immune Status and Function as assessed by ISQ  
3 months 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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   N/A 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet  
Brief Summary   As there was a sudden pandemic outbreak of Novel Corona virus disease all over the World, various herbal remedies have been suggested by the AYUSH ministry and the state government of Tamilnadu for prophylaxis. In need to document the various herbal remedies along with Kabasura kudineer and Nilavembu kudineer in various containment zones and Non- containment zones a questionairre based population study survey will be conducted.
 
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