CTRI Number |
CTRI/2020/06/025855 [Registered on: 13/06/2020] Trial Registered Prospectively |
Last Modified On: |
18/09/2020 |
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
|
|
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= 3 |
Name of Committee |
Approval Status |
IEC MP SHAH GOVERNMENT MEDICAL COLLEGE |
Approved |
IEC MP SHAH GOVERNMENT MEDICAL COLLEGE |
Approved |
IEC MP Shah Government Medical College |
Not Applicable |
|
Regulatory Clearance Status from DCGI
|
|
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not yet |
Brief Summary
Modification(s)
|
This is an Open label, randomized, parallel arms, controlled clinical trial. Study is divided in two groups and enrollment of patients are stopped after total sample size reaches to 80. (Initially study was planned for 60 sample size, but due to limitation of study site and city (Jamnagar, Gujarat) investigations like IgE, D-dimer were not conducted during initial recruitment. Later when this facility started, to reach up to the statistically analyzable figure, study was extended till 80 sample size.) Group one is an interventional group in which tablet AYUSH 64 was given 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)was given. Interventional drug was given for 14 days and follow up period was 14 days after completion of intervention. Patients with less than 80% drug compliance, were dropped out from the trial.
|