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CTRI Number  CTRI/2020/04/024882 [Registered on: 27/04/2020] Trial Registered Prospectively
Last Modified On: 27/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to assess the effectiveness of Ayurvedic formulation in addition to standard of care in COVID-19 positive patients in a tertiary hospital. 
Scientific Title of Study   Effect of an Ayurvedic Formulation as add-on to standard of care in COVID-19 positive patients in a tertiary hospital 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSushila Kataria 
Address  Department of Internal Medicine, 6th Floor,Medanta The Medicity,Sector-38,Gurgaon,Haryana

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  drsushilakataria@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Sushila Kataria 
Address  Department of Internal Medicine, 6th Floor,Medanta The Medicity,Sector-38,Gurgaon

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  drsushilakataria@gmail.com  
 
Details Contact Person
Public Query
 
Name  Mr.Kuldeep K Chauhan 
Address  10th Floor,Medanta The Medicity,Sector-38,Gurgaon,Haryana

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  kuldeep.chauhan@medanta.org  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences 
Council of Scientific and Industrial Research 
Indian Institute of Integrated Medicine,Jammu 
Ministry of AYUSH,Government Of India 
 
Primary Sponsor  
Name  Ministry of AYUSH Government of India 
Address  GPO Complex, AYUSH BHAWAN, B Block, INA, New Delhi, Delhi 110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Medanta Institute of Education and Research  10th Floor,Medanta The Medicity,Gurgaon,Haryana, India-122001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
DrSushila Kataria  Medanta Institute of Education and Research  10th Floor,A wing,Medanta The Medicity,Sector-38
Gurgaon
 
9971918887

drsushilakataria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kashaya(Decoction)  90-100 ml of kashaya of Tinospora cordifolia stem added with 2gms of finelly powdered dried Piperlongum fruit,once in the morning before breakfast and once in the evening before dinner as add on therapy in addition to standard of care medicines 
Comparator Agent  Standard of Care  Patients on Standard care medicines who do not agree to take the ayurvedic medicine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age > 18 years
Written Informed consent is documented
COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test.
Can take oral medicines
Mild-moderate grade of the disease

Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection. 
 
ExclusionCriteria 
Details  Known sensitivity to any of the ingredients
Bleeding haemorrhoids
Serious stages of the illnesses
ICU admitted patients
Pre-existing GI symptoms like nausea or vomiting 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients progressing to serious/critical stage of disease
Progress of disease as per clinical severity score (COCSS)
No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity
No. of days taken to test negative for COVID, total days to discharge frm hospital
Profiling acc to tridosha
Defining the disease according to Ayurveda 
Observed and recorded on all days of the treatment as relevant
Recorded on the days when the investigation is done
Recorded on the days when the medication is changed in type or dose
Recorded as average of pO2 in a day
Recorded as volume of O2 supplied etc 
 
Secondary Outcome  
Outcome  TimePoints 
No. of days to first clinical symptoms, and what it is
No. of days to and of GI symptoms and what they are
No. of days of fever and quality of fever (intermittent/remittent, severity, management)
No. of days to Cytokine storm, Severity.
No. of days it takes to need for ICU mngmnt
No. of days of oxygen support/Frequency of need, Scale of hypoxia,
Need for High flow oxygen,
Number of days to and of Orogastric feeding
Other complications
The impact on laboratory parameters 
Observed and recorded on all days of the treatment as relevant
Recorded on the days when the investigation is done
Recorded on the days when the medication is changed in type or dose
Recorded as average of pO2 in a day
Recorded as volume of O2 supplied etc 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  
28/04/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  

The project is aimed to assess the effect in clinical outcomes from administering an integrative medicine protocol which subsumes Ayurvedic interventions as part of the standard of care COVID 19 management versus clinical outcomes in COVID 19 patients being administered standard of care alone with following objectives

 

Primary objectives:    Assessing the effect of the Ayurveda drug combination of Tinospora cordifolia and Piper longum in the progression of the disease, its severity and clinical outcome.

 

Secondary objectives:    Study the progress of the disease in detail and in real-time to develop better understanding of the pathogenesis and different stages of the disease from Ayurvedic perspective, clinical data and observations based on patient response to interventions.

 

2.      Correlating the clinical investigation parameters of different stages of the pathogenesis with Ayurveda understanding of the sub-stages of the disease.



 

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