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CTRI Number  CTRI/2020/06/025769 [Registered on: 09/06/2020] Trial Registered Prospectively
Last Modified On: 23/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha
Preventive 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study
Modification(s)  
A prophylactic interventional study to determine the possible protective effect of Siddha Polyherbal formulation Kabasura Kudineer against the COVID 19 on intermittent, month-long consumption by public with close contacts to COVID patients and frontline workers in Tamil Nadu, India 
Scientific Title of Study
Modification(s)  
A prospective Non randomized open label controlled intervention study on the effect of Polyherbal Siddha formulation Kabasura kudineer 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  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

Modification(s)  
Name  Dr K Suresh 
Designation  Associate professor, Department of Kuzhandhai maruthuvam 
Affiliation  National institute of Siddha  
Address  National Institute of Siddha Tambaram Sanatorium
National Institute of Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr N J Muthukumar 
Designation  Head of the department , Department of Sirappu maruthuvam 
Affiliation  National institute of Siddha  
Address  National Institute of Siddha Tambaram Sanatorium
National Institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962006843  
Fax    
Email  njmuthu@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, chennai - 47 
 
Primary Sponsor  
Name  National institute of Siddha Ministry of AYUSH  
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
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Suresh  National Institute of Siddha  GST Road Tambaram Sanatorium chennai 47
Kancheepuram
TAMIL NADU 
9962571137

drsureshherbal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Highrisk population and frontline workers of COVID19 Pandemic  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Kabasura kudineer   5- 10gms of Kabasura kudineer drug boiled with 240ml of water will be reduced to 60 ml, filtered and Consumed within 3 hours. Concoction will be freshly prepared for every dose. Time of Administration: This dose will be administered once a day just before or after food. 
Comparator Agent  Standard of Care  General public and frontline workers who have taken/given Allopathic Standard of Care like Vitamins and/or other drugs for Covid prevention.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All the willing frontline health workers, police personnel and other public servants inclusive of those with direct / primary contacts with COVID positives (High risk and moderate risk exposures). 
 
ExclusionCriteria 
Details  Not willing to sign informed consent.
Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of participants protected during the outbreak of COVID 19 compared between the Kabasura Kudineer taken and Standard of Care taken groups   Assessment will be done at Baseline and 30th day from the start of Prophylactic intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
General and specific health status as assessed.
❑ Immune Status and Function as assessed by ISQ
❑ Progression of disease in the participants who turned COVID 19 positive 
6 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="40000"
Sample Size from India="40000" 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Brief Summary
Modification(s)  
As there is a sudden outbreak of Novel coronavirus all over the world there is a need of drug to prevent the COVID  infection from direct contact persons who are in high , moderate,Low risks of the disease. To document the prophylatic efficacy of the drug Kabasura kudineer among the high risk population, Moderate risk and low risk frontline workers. This study will be conducted as Non randomized study among the high, moderate and low risk frontline workers in Tamil nadu.  
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