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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   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  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Bhardwaj 
Designation  Additional Professor, Community and Family Medicine. 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
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 of Contact Person
Scientific Query  
Name  Dr Jaykaran Charan 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
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 of Contact Person
Public Query  
Name  Prof Pawan kumar Godatwar 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
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  
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  
No of Sites = 1  
Name of Principal Investigator  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
RAJASTHAN 		 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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
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 patients referred  Baseline to one month 
Number of cases that required invasive or non-invasive oxygen therapy during the intervention.  Baseline to one month 
Number of cases that progressed to multi-organ failure while under clinical trial  Baseline to one month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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