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CTRI Number  CTRI/2020/05/025215 [Registered on: 16/05/2020] Trial Registered Prospectively
Last Modified On: 15/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of Mild COVID 19 patients. 
Scientific Title of Study   A prospective, single centre, randomized open labelled comparative clinical study to evaluate the effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of asymptomatic COVID 19 patients. 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr S Natarajan 
Address  Arignar Anna Hosiptal Campus Arumbakkam Chennai

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  drnatarajan78@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr S Natarajan 
Address  Arignar Anna Hospital Campus Arumbakkam Chennai

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  drnatarajan78@gmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr C Anbarasi 
Address  Arignar Anna hospital Campus Arumbakkam Chennai

Chennai
TAMIL NADU
600106
India 
Phone    
Fax    
Email  dranbu1208@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Government Stanley Medical College,No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001  
 
Primary Sponsor
Modification(s)  
Name  Dean 
Address  Government Stanley Medical College, No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Central Council for Research in Siddha  Arumbakkam, Chennai 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr S Natarajan  Government Stanley Medical College  101,F Block, COVID Division, Department of Medicine, No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001
Chennai
 
9843086050

drnatarajan78@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Stanley Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kabasura Kudineer  60 ml bd for 14 days 
Comparator Agent  Vitamin C, Zinc supplementation  Vitamin C - 60000IU OD for 14 days Zinc supplementation - 100mg od for 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 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, 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   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in incidence of clinical symptoms of COVID 19
Negative conversion of SARS-CoV-2
Reduction in Viral load of SARS-CoV-2 at the end of treatment
Examine the levels immune markers and inflammatory markers  
14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of in hospital time
adverse events/effects
Siddha Udaliyal assessment
Siddha Uyir thathukkal and udal thathukkal assessment 
14 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   25/05/2020 
Date of First Enrollment (Global)  No Date Specified 
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   Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, SARS-CoV-2, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. At present, there is limited evidence from randomized clinical trials to support any vaccines or pharmacological treatments from conventional medicine for COVID-19According to Siddha system of medicine, the symptoms and signs of COVID-19 are identified as the aggravation of Iyam and which later associated with other Uyir thathukkal Vali and Azhal and expressed as Thontham (Mukkutram) leads to sanni. In this context, one of the classical formulations from Siddha system of medicine is Kabasura kudineer (KSK) consists of 15 herbals ingredients which individually has anti-viral activity has been recommended for the prophylaxis and management of COVID 19.  Vitamin c and zinc supplementation(CZ) is being prescribed for the COVID19 positive asymptomatic patients admitted in isolation ward. The role of CZ in the management of COVID19 is still not clear. Therefore, study will compare the effect of KSK and CZ in terms of negative conversion of SARS CoV- 2 infection.  

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