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CTRI Number  CTRI/2020/06/025874 [Registered on: 15/06/2020] Trial Registered Prospectively
Last Modified On: 15/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To observe the effect of Siddha formulation Kabasura kudineer in COVID 19 patients 
Scientific Title of Study   A randomized open labeled clinical study to compare the effectiveness of Kabasura kudineer and Vitamin-C Zinc supplementation in the management of asymptomatic SARS-CoV-2 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Sankararaj 
Designation  Assistant Medical Officer Siddha 
Affiliation  Government Theni Medical College and Hospital 
Address  Siddha wing Government Theni Medical College and Hospital Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Theni
TAMIL NADU
625531
India 
Phone  9965897075  
Fax    
Email  drsankararaj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Sankararaj 
Designation  Assistant Medical Officer Siddha 
Affiliation  Government Theni Medical College and Hospital 
Address  Siddha wing Government Theni Medical College and Hospital Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Theni
TAMIL NADU
625531
India 
Phone  9965897075  
Fax    
Email  drsankararaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr C Anbarasi 
Designation  Research Officer Siddha 
Affiliation  Siddha Central Research Institute 
Address  Arignar Anna Hospital Campus Arumbakkam Chennai
Arignar Anna Hospital Campus Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India 
Phone  8754416050  
Fax    
Email  dranbu1208@gmail.com  
 
Source of Monetary or Material Support  
Government Theni Medical College, Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 and Central Council for Research in Siddha,Arignar Anna Hospital Campus, Arumbakkam, Chennai 
 
Primary Sponsor  
Name  Dean Government Theni Medical College 
Address  Government Theni Medical College Kochi Madurai Dhanushkodi Road Theni Allinagaram Tamil Nadu 625531 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Director General  Central Council for Research in Siddha Ministry of AYUSH Arumbakkam Chennai 600106 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P Sankararaj  Government Theni Medical College and Hospital  Kochi Madurai Dhanushkodi Road Theni Allinagaram Tamil Nadu 625531
Theni
TAMIL NADU 
9965897075

drsankararaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Theni Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kabasura kudineer  Siddha medicine 30 – 60 ml twice daily orally 
Comparator Agent  Zinc and Vitamin C   Zinc -100 mg, Vit C – 60000 IU twice daily orally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Laboratory confirmed COVID-19 without symptoms
2.Consenting to participate in the study and sign the informed consent 
 
ExclusionCriteria 
Details  1.Patient with co morbid conditions like DM, HT and BA.
2.Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19.
3.Pregnant and mothers those who have a pregnancy plan.
4.Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the study.
5.People who have been allergic to Siddha medicine or intolerant to taking medicine.
6.Patients participating in other COVID-19 clinical trials.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in incidence of clinical symptoms like fever, cough and breathlessness.
2.Negative conversion of SARS-CoV-2 by 14 days
3.Reduction in Viral load of SARS-CoV-2 at the end of treatment (0, 7, 14 days)
4.Examine the levels of immune markers and inflammatory markers (IgG, IgM, IgA, Th1 (TNF-Alfa, IFN-gamma, IL2) Th2 (IL6, IL10) at the end of treatment (0, 7, 14 days)
 
14 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduction in incidence of complications.
2.Reduction of in hospital time.
3.Laboratory markers
4.Adverse events/effects
 
14 days 
 
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 2 
Date of First Enrollment (India)   24/06/2020 
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   NIL 
Brief Summary   Siddha system of medicine has contributed in lowering health burden during public health emergency. It is proposed to have a good potential to combat COVID-19. One of the classical Siddha formulations  is Kabasurakudineer (KSK) consists of 15 herbal ingredients. This study is proposed to observe the effect of Kabasura kudineer compared with Viamin C and Zinc supplements in asymptomatic patients with  SARS CoV- 2 infection.  
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