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CTRI Number  CTRI/2020/06/025768 [Registered on: 09/06/2020] Trial Registered Prospectively
Last Modified On: 09/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19 
Scientific Title of Study   An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with 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 MEENAKUMARI R 
Designation  DIRECTOR 
Affiliation  NATIONAL INSTITUTE OF SIDDHA,  
Address  NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Chennai
TAMIL NADU
600047
India 
Phone  9176534465  
Fax    
Email  mkumari474@gmail.com  
 
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, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Kancheepuram
TAMIL NADU
600045
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, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Kancheepuram
TAMIL NADU
600045
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram 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 
Chengalpattu Medical College Hospital  Chengalpattu Medical College Hospital, Chengalpattu - 603001. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G J CHRISTIAN   Chengalpattu Medical College Hospital  Chengalpattu Medical College Hospital, Chengalpattu - 603001.
Kancheepuram
TAMIL NADU 
9962545930

christianvijila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instuitional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B342||Coronavirus infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kabasura kudineer, Amukkara churnam and Nellikai ilagam  Kabasura kudineer: 10gms of drug boiled with 240ml of water will be reduced to 60 ml, filtered and consumed within 3 hours. Decoction will be freshly prepared for every dose. Convalescent medicine namely NELLIKAI ILAGAM 5gm BD and AMUKKARA CHURNAM 2gm BD. The intervention will be administered for 30 days or till the RT PCR becomes negative whichever is earlier 
Comparator Agent  nil  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Male, Female and Transgenders.
 Age between 18 to 85 years
 COVID 19 positive asymptomatic / pre symptomatic, mild and moderately symptomatic patients.
 Willing to consent to the study. 
 
ExclusionCriteria 
Details  High risk groups-Patients with other severe medical conditions requiring intensive management.s
Other viral pneumonia
Patients who have received organ transplantation in the past 6 months or planning surgery
Patients with severe or critical covid-19 infections. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. RT PCR conversion within first week with accelerated recovery as compared to control group  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Possible reduction of viral load data in subsets of both groups both at baseline and at 7 days, and14 days or at recovery or 30 days whichever is earlier..
 Sub group analysis for male, female and Age groups will also be studied in each group. Number of days on treatment before recovery and case fatality rate if any will be documented. 
6 MONTHS 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/06/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   COVID 19 has almost entered every part of the world. Treatments proposed is ineffective or minimally effective. Hence, it is important to find drugs in appropriate time. Kabasura kudineer is a Siddha drug proposed by entire Siddha fraternity to combat COVID 19 disease after analyzing its nature. It is proven to be effective in preclinical analysis. It is to be analysed clinically through this study.

 
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