CTRI Number	CTRI/2020/06/026002 [Registered on: 21/06/2020] Trial Registered Prospectively
Last Modified On:	20/06/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Study of use of Ayurveda Intervention (Ayush-64) in COVID 19
Scientific Title of Study	Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush-64) add-on therapy for patients with COVID-19 infection (Stage I)-An Open labelled, Parallel Group, Randomized controlled clinical trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Pankaj Bhardwaj  Address  Room No. 204 Department of Community and Family Medicine All India Institute of Medical Sciences, Jodhpur Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN 342005 India  Phone  8003996903   Fax     Email  pankajbhardwajdr@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Jaykaran Charan  Address  Room no. C - 263 Department of Pharmacology All India Institute of Medical Sciences, Jodhpur Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN 342005 India  Phone  9825219196   Fax     Email  dr.jaykaran78@gmail.com
Details Contact Person Public Query Modification(s)	Name  Prof Pawan kumar Godatwar  Address  Room no. 127 PG Dept. of Roga & Vikriti Vijnana, National Institute of Ayurveda, Jaipur Telephone Nos Off : 0141-2635753 ext-266 Fax : 0141- 2635709 Jaipur RAJASTHAN 302002 India  Phone  9314502834   Fax     Email  gpawankumar@rediffmail.com
Source of Monetary or Material Support Modification(s)	National Institute of Ayurveda (An autonomous body under the ministry of AYUSH) Madhav Vilas Palace, Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJASTHAN) INDIA Contact no: 91-141-2635816 Fax. No.: 91-141-2635709 Email Id.: nia-rj@nic.in
Primary Sponsor	Name  National Institute of Ayurveda  Address  Madhav Vilas Palace, Jorawar Singh Gate, Amer Road JAIPUR 302002 RAJASTHAN INDIA   Type of Sponsor  Other [National Institute of Ayurveda]
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 Pankaj Bhardwaj  All India Institute of Medical Sciences, Jodhpur  Room No. 204 Department of Community and Family Medicine All India Institute of Medical Sciences, Jodhpur Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005 Jodhpur   8003996903 pankajbhardwajdr@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee, AIIMS Jodhpur  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 Modification(s)	Type  Name  Details  Intervention  AYUSH 64  2 Capsules/Tablets (500mg each) thrice daily by oral route for one month   Comparator Agent  Standard treatments as per guidelines  NA
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1. Patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection) 2. Participants who can take medicines orally. 3. Patients willing to provide signed informed consent.
ExclusionCriteria	Details  1. Pregnant, Lactating women, patients with CKD (Chronic Kidney Disease). 2. Not willing to participate in the study.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Clinical cure rate: Time to negative conversion of COVID19.  Time to event
Secondary Outcome	Outcome  TimePoints  Duration of fever and each of the respiratory symptoms  Baseline to one month  Improvement in hematological and laboratory parameters (CBC, LFT, RFT, RBS, ESR, Hs-CRP, LDH, CXR, ABG, S. Ferritin, D-dimer, ECG)  Baseline to one month  No of cases Reporting any ADR/AE  Baseline to one month  Number of cases that progressed to multi-organ failure while under clinical trial  Baseline to one month  Number of cases that required invasive or non-invasive oxygen therapy during the intervention.  Baseline to one month  Number of patients referred  Baseline to one month
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	Phase 2
Date of First Enrollment (India)	01/07/2020
Date of First Enrollment (Global)	No Date Specified
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 Modification(s)	NIL
Brief Summary	COVID -19 has emerged as the latest pandemic affecting millions of the people world over. Many interventions are being tried to prevent and treat the same. Central Council for Research in Ayurvedic Sciences has developed a poly-herbal drug “AYUSH 64” which is considered to be effective in diseases like malaria, pyrexia of unknown origin, filariasis etc. This drug was found to be beneficial in influenza like illness and found to be safe in previous studies. This study was designed to explore its efficacy and safety of “AYUSH 64”in COVID -19 patients having mild disease. In this trial, we are going to enroll 30 confirmed COVID-19 patients having very mild disease in intervention and control group each. Intervention group will be given 2 capsules/tablets (500 mg each) every 8 hourly while control group will be on standard treatment as per the institution policy. The primary endpoint for this trial is “time to negative conversion of COVID 19” based on the report of RTPCR. Various secondary endpoints like duration of fever and respiratory symptoms, hematological parameters, adverse events, no. of patients referred, number cases requires oxygen therapy and no. of cases progressed to multiorgan failure will also be compared between intervention and control groups.