CTRI Number	CTRI/2020/05/025338 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On:	23/05/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Single Arm Trial
Public Title of Study	Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms
Scientific Title of Study	Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms)- An open label single arm prospective clinical trial
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NA  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Manoj Shamkuwar  Address  Department of Panchakarma A and U Tibbia College and Hospital Govt. of NCT of Delhi Karol Bagh, New Delhi Central DELHI 110005 India  Phone  9354925019   Fax     Email  manoj_1873@yahoo.co.in
Details Contact Person Scientific Query Modification(s)	Name  Dr BabitaYadav  Address  Room No 119 A Central Council for Research in Ayurvedic Sciences, D Block Janakpuri, New Delhi South West DELHI 110058 India  Phone  9910171143   Fax     Email  drbabitayadav@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Shivshankar Rajput  Address  IPD Building First Floor Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi West DELHI 110026 India  Phone  8460819669   Fax     Email  shivshankerdr@gmail.com
Source of Monetary or Material Support	Central Council For Research in Ayurvedic Sciences Ministry of AYUSH Govt of India
Primary Sponsor	Name  Central Council For Research in Ayurvedic Sciences  Address  J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Manoj Shamkuwar  A and U Tibbia College and Hospital  COVID 19 Ward Maternity and Medicine Block Ajmalkhan Road Karol Bagh New Delhi Central   9423039441 manoj_1873@yahoo.co.in
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  A and U Tibbia College IEC  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  Ayush 64  Dose: 2 capsules (500 mg each) thrice daily (2-2-2) Dosage form: Tablets Route of Administration: Oral Time of Administration: Thrice a day after food Anupana: Warm Water Duration of therapy: 14 days   Comparator Agent  Not applicable  Not applicable
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1.Mild to moderate cases registered in Ayurved and Unani Tibbia College and Hospital Designated as COVID Health Center above the age of 18 years, with COVID 2019 (Confirmed by RT-PCR) quarantined at identified hospital setup. 2.Participants who can take medicines orally 3.Patients willing to provide signed informed consent
ExclusionCriteria	Details  1.Cases of severe vomiting which would make oral administration of medicine difficult. 2.Cases of respiratory failure and requiring mechanical ventilation. 3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. 4.Patients with COVID 19 in critical condition or ARDS or NIAD 8 –point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation 5.Pregnant or lactating women 6.Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below. b) Number of patients showing ‘clinical recovery’.   a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below. [Time frame: Daily] b) Number of patients showing ‘clinical recovery’. [Time frame: Daily]
Secondary Outcome	Outcome  TimePoints  1. Percentage of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test beginning from ‘first day of clinical recovery’ or day after onset of symptoms depending on whichever of the two time points is first achieved 2. Improvement in selected laboratory parameters:, differential and total leukocyte counts, , acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG)   Time frame: 8th day or 15th day
Target Sample Size	Total Sample Size="40" Sample Size from India="40"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	02/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="5"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	NIL
Brief Summary	COVID-19 has emerged as the latest pandemic, that erupted in the Wuhan City of People’s Republic of China in December 2019, which is affecting human health and economy across the world.Drug repurposing, which is defined as identifying alternative uses for approved or investigational drugs outside their defined indication, could be a possible way to overcome the time limitation of research and development needed to design a therapeutic drug to combat the pathogen.Ayurveda and traditional systems of Medicine in India have been treating diseases of infectious and non-infectious origin equally with expansive success rates, treating the patients through an individualized person to person approach depending upon the presentation of clinical symptoms in each.CCRAS, apex body for research and development in Ayurveda in India under Ministry of AYUSH has developed a poly-herbal drug ‘AYUSH 64’ through extensive pharmacological, toxicological and clinical studies.It is found to be effective in fevers of unknown etiology, filarial lymphangitis and derangement of liver function besides its anti-malarial activity.Taking leads from the clinical experiences of physicians who had successfully used AYUSH-64, for management of Influenza like Illness (ILI), a pilot study was conducted by this Council. This study was done in 30 cases of flu like illness, among whom, 28 participants recovered without any further medication. This lead to the idea of repurposing AYUSH 64 for use in the management of Covid-19 positive cases which also present with Influenza like symptoms owing to affliction of respiratory tract.