FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025093 [Registered on: 11/05/2020] Trial Registered Prospectively
Last Modified On: 10/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   Study of effect of Yashtimadhu tablet for the prevention of COVID -19 on healthy individuals.  
Scientific Title of Study   Observational Study of YASHTIMADHU TABLET intake as a preventive measure in pandemic of COVID-19 – An open label, Randomized, Controlled, Prospective, interventional, Community-based Cclinical study on healthy subjects  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Babu 
Designation  Assistant director Incharge 
Affiliation  Regional Ayurveda research institute for skin disorders 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  8096455323  
Fax    
Email  narivbd.vijayawada@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Babu 
Designation  Assistant director Incharge 
Affiliation  Regional Ayurveda research institute for skin disorders 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  8096455323  
Fax    
Email  narivbd.vijayawada@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujata pundlikrao Dhoke 
Designation  Research officer(Ayu) 
Affiliation  Regional Ayurveda research institute for skin disorders 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  9824744048  
Fax    
Email  sujubasic@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH Govt of India 
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  Ministry of Ayush , Ayush Bhavan, B Blick GPO complex, INA New Delhi110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujata Pundalikrao Dhoke  Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada   Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada
Krishna
ANDHRA PRADESH 
9824744048

sujubasic@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Vijayawada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Yashtimadhu tablet   YASHTIMADHU TABLET -250 mg X 2 tablets b.d. for one month  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  68.00 Year(s)
Gender  Both 
Details  1.Adult Male or Female subjects above the age of 18 years to 68 years.
2.Subjects who are from a community where at least 1 confirmed case is already identified.
3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
 
 
ExclusionCriteria 
Details  1.Pregnant and Lactating females
2.Known cases of uncontrolled Diabetes and Hypertension.
3.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
5.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
6.Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention.
8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care   15,30 and 45th day  
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparative assessment of severity of Covid-19 infection in subjects taking YASHTIMADHU TABLET and those not taking it in following situations:
a) Assessment of subjects not requiring hospitalization
b) Severity of symptoms of hospitalized patients in wards
c) Patients requiring ICU admission / Ventilator support
2. Global assessment of overall change as per the investigator (Efficacy assessment)
 
15,30 and 45th day 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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/ Phase 3 
Date of First Enrollment (India)   18/05/2020 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Brief Summary  

Currently, there are no specific vaccines or treatments for COVID-19. Evidence is needed on pre-exposure prevention, post-exposure prevention, and patient management.To address these challenges and accelerate the research needed in resource-limited settings, we propose this study to evaluate Ayurveda Intervention as a prophylaxis for COVID-19 infection in healthy adult volunteers with

Primary outcome  of  Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care and Secondary outcome of Comparative assessment of severity of Covid-19 infection in subjects taking YASHTIMADHU TABLET and those not taking it in following situations:

a)      Assessment of subjects not requiring hospitalization

b)      Severity of symptoms of hospitalized patients in wards

c)      Patients requiring ICU admission / Ventilator support,     Global assessment of overall change as per the investigator (Efficacy assessment)   Safety assessment by evaluation of occurrence of AE/SAE due to consumption of Ayurveda Intervention

 
Close