CTRI Number	CTRI/2020/04/024882 [Registered on: 27/04/2020] Trial Registered Prospectively
Last Modified On:	17/12/2020
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 Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  Medanta Institutional Ethics Commitee  Approved  Medanta Institutional Ethics Committee  Not Applicable
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.