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CTRI Number  CTRI/2020/05/025298 [Registered on: 21/05/2020] Trial Registered Prospectively
Last Modified On: 21/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Siddha Intervention Population Study. 
Scientific Title of Study   A prospective non-randomised open label controlled interventional study on the e ffe ct of Siddha intervention as a prophylactic measure among high risk population (Health Care Workers/ Containment Zone population) exposed to COVID 19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKKanakavalli 
Designation  Director General 
Affiliation  siddha central research Institute 
Address  Anna Hospital Campus Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  drkkanakavalli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKKanakavalli 
Designation  Director General 
Affiliation  siddha central research Institute 
Address  Anna Hospital Campus Arumbakkam
Anna Hospital Campus Arumbakkam
Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  drkkanakavalli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKKanakavalli 
Designation  Director General 
Affiliation  siddha central research Institute 
Address  Anna Hospital Campus Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  drkkanakavalli@gmail.com  
 
Source of Monetary or Material Support  
MINISTRY OF AYUSH. AYUSH BHAWAN, B-Block, GPO COMPLEX,. INA COLONY, NEW DELHI - 11-0023 
 
Primary Sponsor  
Name  Central council for research in Siddha 
Address  Central Council for research in Siddha Siddha central research institute Anna hospital campus Arumbakkam Chennai 
Type of Sponsor  Research institution 
 
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 
PSathiyarajeswaran  siddha central research institute  Departmrnt of clinical research Siddha central research Institute
Chennai
TAMIL NADU 
8754495186

p.sathiyarajeswaran@gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIDDHACENTRALRESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  B972 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kabasurakudineer Nilavembukudineer  Siddha official formulation once daily for 14 days.  
Comparator Agent  Personal Sanitation and Environmental Sanitataion  Sanitisers Handwash Masks Gloves for 6 months 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  68.00 Year(s)
Gender  Both 
Details  1. Adult Male or Female subjects above the age of 5 years to 68 years
2. Subjects who are from a community where at least 1 confirmed case is already identified.
3. 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  Pregnant and Lactating females
Known cases of uncontrolled Diabetes and Hypertension COPD or Lung related diseases
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 Siddha 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 
1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care   1stweek 2ndweek 3rd week and 4th week  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of side effects non hospitalization no severe symptoms no ventilatory support no of days in ICU  1stweek 2ndweek 3rd week and 4th week  
 
Target Sample Size   Total Sample Size="21500"
Sample Size from India="21500" 
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)   25/05/2020 
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   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   Ayush Ministry during  March 2020 released an advisory to Mitigate Covid19 with AYUSH intervention Kabasurakudineer and Nilavembukudineer have been listed among prophylactics and suspected cases. AYUSH also advised all research councils to test the Intervention for their prophylactic effect. This  - Non Randomised open labelled prophylactic intervention study will help to cull out the real effect of this drug. 
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