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CTRI Number  CTRI/2020/06/025763 [Registered on: 09/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
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   A Randomized controlled Clinical Trial to determine the efficacy of Siddha drugs in COVID 19 patients 
Scientific Title of Study   A Randomized controlled Clinical Trial to determine the complementary effect of selected Siddha formulations in facilitating the possibility of accelerated recovery in COVID 19 patients.  
Trial Acronym  SIDCOVID 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakumari R 
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  044-22381314  
Email  mkumari474@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  G J Christian 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium
National Institute of Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  G J Christian 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium
National Institute of Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
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 
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 
Dr G J Christian   SRM Medical college Hospital and Research centre  SRM Medical college Hospital and Research centre, Kaattankulathur, Chengalpattu Dt., Tamilnadu, India.
Kancheepuram
TAMIL NADU 
9962545930

christianvijila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Kabasura kudineer, Amukra churnam, Thalisadhichurnam, Adathodai Manappagu   Kabasura kudineer 60ml tid in will be given till the patients becomes negative or 30 days which ever earlier. Amukra churnam 2g bid with honey or milk (in ymptomatics & bid in asymptomatics diabetics),thalisadhichurnam 2g bid with honey or milk (in diabetics) ,Adathodai Manappagu 10ml bid with waterwill be given till the patients becomes negative or 30 days which ever 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 and severely symptomatic patients.
 Willing to consent to the study. 
 
ExclusionCriteria 
Details  High risk groups (Patients with Complications of Diabetes, Heart diseases, Cancer and Pregnancy)
 Multi organ failure Syndrome (MODS).
 Patients participating in other COVID 19 trials. 
 
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 Reduction of symptoms and
Recovery of patients from COVID 19 disease in a time bound manner.Conversion of RT PCR negative within first week of accelerated recovery  
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Possible reduction of viral load data in subjects both at baseline and at 7 days, and 14 days or at recovery or 30 days whichever is earlier..
 Number of days on treatment before recovery and Case fatality rate will also be noted.
 Reduction in Signs and symptoms like Fever, cough, breathlessness, and improvement in O2 saturation (SpO2) and PaO2/FiO2 becoming 300mg/Hg in patients with severe grade and ARDS. 
6 MONTHS 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   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)  Not Yet Recruiting 
Publication Details   Nil 
Brief Summary   As there is a sudden outbreak of Novel Coronavirus disease all over the world. As there is no direct drug against the disease spread, it is a time needed action of usage of AYUSH drugs in management. Various drugs have cited by AYUSH ministry and State government for management of the disease spread like Kabasura kudineer, Amukkara choornam etc. This study will be conducted based on the Prelimmary analysis and literature evidence of drugs namely Kabasura kudineer, Amukkara choornam, Thalisathi choornam and Adathodai manapaggu  among the sample consists of 18 years and above COVID-19 – RT PCR +ve patients declared by Tamil Nadu Government accredited labs admitted to COVID 19 ward at SRMMCH / NIS or quarantined Govt. facilities or at home quarantine. The subjects will be randomly allocated to both the groups. This study is carried out to document scientifically the therapeutic efficacy of these drugs against Novel Corona virus disease. 
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