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CTRI Number  CTRI/2020/05/025088 [Registered on: 09/05/2020] Trial Registered Prospectively
Last Modified On: 08/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of GUDUCHI TABLET on healthy individuals to prevent covid 19. 
Scientific Title of Study   Observational Study of GUDUCHI TABLET intake as a preventive measure in pandemic of COVID-19 – An open label, Randomized, Controlled, Prospective, Interventional, Community-based Clinical study on healthy subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B vankatshwarlu 
Designation  Research officer(Ayu) 
Affiliation  Regional ayurveda research instutute vijayawada 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  6301340787  
Fax    
Email  drcvenkat@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B vankatshwarlu 
Designation  Research officer(Ayu) 
Affiliation  Regional ayurveda research instutute vijayawada 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  6301340787  
Fax    
Email  drcvenkat@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B vankatshwarlu 
Designation  Research officer(Ayu) 
Affiliation  Regional ayurveda research instutute vijayawada 
Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.

Krishna
ANDHRA PRADESH
520015
India 
Phone  6301340787  
Fax    
Email  drcvenkat@rediffmail.com  
 
Source of Monetary or Material Support  
Ministry of Ayush government of India 
 
Primary Sponsor  
Name  central council for rsearch in ayurvedic sciences 
Address  61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Research institution 
 
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 K Anumol  Regional Ayurveda research institute Vijayawada  Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada
Krishna
ANDHRA PRADESH 
8075021635

dranumolk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Vijayawada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participant will select from area where atleast one covid 19 positive patient available  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guduchi tablet  Tab Guduchi 500mg twice daily for one month 
Comparator Agent  nil  nil 
 
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 froma 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   15th day, 30th day, 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparative assessment of severity of Covid-19 infection in subjects taking GUDUCHI 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)
 
15th day , 30th day and 45 th 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 1/ Phase 2 
Date of First Enrollment (India)   20/05/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Brief Summary  

There is no available vaccine against COVID-19 infections and no drug with proven clinical efficacy, although there are several candidates that might be effective in prevention or treatment. Encouragingly, the response from the research community to the pandemic of Coronavirus disease 2019 (COVID-19) has been vigorous.Guduchi is Rasayana drug which improves immunity. In This study will give Guduchi tab 500mg twice daily for one month to healthy individuals to prevent Covid 19. We are selecting the patient from community  where atleast one covid 19 patient is present.The possible outcomes of thestudy will be Primary outcome 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 outcomev will be 
   Comparative assessment of severity of Covid-19 infection in subjects taking Guduchi  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)
3.     Safety assessment by evaluation of occurrence of AE/SAE due to consumption of Ayurveda Intervention

  
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