FULL DETAILS (Read-only)

CTRI Number  CTRI/2020/06/025855 [Registered on: 13/06/2020] Trial Registered Prospectively
Last Modified On: 19/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of AYUSH 64 in COVID 19 
Scientific Title of Study   Efficacy of Ayurveda Intervention (AYUSH 64) as add-on therapy in COVID 19 patients - An open label randomized controlled trial 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Anup Thakar 
Address  Director office IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  directoripgt@ayurveduniversity.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Mandip Goyal 
Address  Room no 403 Kayachikitsa department IPGT and RA Gujarat Ayurved University Jamnagar agar

Jamnagar
GUJARAT
361008
India 
Phone  9427572306  
Fax    
Email  kaurmandip22@yahoo.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Sagar M Bhinde 
Address  Room no 533 kaumarbhritya department IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9662512158  
Fax    
Email  sgrbhinde@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
IPGTRA Gujarat Ayurved University Jamnagar 
 
Primary Sponsor  
Name  IPGT and RA  
Address  Director office IPGT and RA Gujarat Ayurved University Jamnagar Gujarat India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Anup Thakar  IPGT and RA Hospital Jamnagar  2nd floor IPD ward
Jamnagar
 
9427776660

directoripgt@ayurveduniversity.com 
Dr Yagnik Chotala  Guru govind singh government hospital Jamnagar   COVID ward Department of Medicine
Jamnagar
 
9925564861

cyagnik27@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC MP SHAH GOVERNMENT MEDICAL COLLEGE  Approved 
IEC MP SHAH GOVERNMENT MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYUSH 64   AYUSH 64 02 Capsules of 500mg each orally thrice daily for 14 days as add-on therapy to supportive and symptomatic allopathic treatment for COVID 19 patients 
Comparator Agent  Control arm  Supportive or symptomatic allopathic treatment as per guideline of study site hospital for COVID 19 patients  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Asymptomatic or minimal symptomatic COVID 19 patients Patients having 0 to 4 score as per the WHO ordinal scale for clinical improvement
Age 18 to 70years
Patients who can take oral medicine
Patients who are ready to give written consent
 
 
ExclusionCriteria 
Details  Age below 18 and above 70years
Patients having severe symptoms of COVID19
Patients on mechanical ventilator or organ support
Patients do not able to take oral medication
Pregnant and lactating women
Oncological diseases and other systemic uncontrol conditions such as HTN diabetes etc
Liver or kidney malfunctions.
Severe pneumonia Acute respiratory distress syndrome Sepsis and Septic Shock
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ordinal scale for Clinical improvement as per WHO
Duration on mechanical ventilator
All cause mortality
 
0 7 14 and 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Duration on oxygen therapy  0 7 14 and 28th day 
Number of cases reporting any ADR AE
 
0 7 14 and 28th day 
Number of patients developed symptoms   0 14 and 28th day 
Number of patients who needed mechanical ventilator   0 14 and 28th day 
Number of patients who needed oxygen therapy   0 14 and 28th day 
Total duration of symptomatic phase  0 14 and 28th day 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2020 
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   not yet 
Brief Summary
Modification(s)  

It is an Open label, randomized, parallel arms, controlled clinical trial. Study is divided in two groups and each group having 30 patients. Group one is an interventional group in which AYUSH 64 is taken as add-on therapy to supportive and symptomatic allopathic treatment for COVID 19 patients. Second group is control group in which standard treatments (supportive/symptomatic allopathic treatment for COVID 19 patients as per guideline of study site hospital) will be given. Interventional drug will be given for 14 days and follow up period will be 14 days after completion of intervention. If there is more than or equal to 80% drug compliance, the participant would be continued in the trial. The drug compliance will be assessed during each visit by investigator.

 

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