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CTRI Number  CTRI/2020/05/025488 [Registered on: 31/05/2020] Trial Registered Prospectively
Last Modified On: 28/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study on Guduchi Ghana Vati as a preventive remedy in pandemic of COVID-19 
Scientific Title of Study   An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study to Evaluate Safety and Efficacy of Guduchi Ghana Vati as a Preventive Remedy on Healthy Individuals in Pandemic of COVID-19  
Trial Acronym  GGVC19 
Secondary IDs if Any  
Secondary ID  Identifier 
NIA-CVD-19/2020/01 Version 1.0 Dated 20th May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Sanjeev Sharma 
Designation  Director 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (RAJASTHAN) INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  09418079691  
Fax    
Email  profsanjeevhp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PawanKumar Godatwar  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan Jaipur, RAJASTHAN

Jaipur
RAJASTHAN
302002
India 
Phone  9314502834  
Fax    
Email  gpawankumar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PawanKumar Godatwar  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan Jaipur, RAJASTHAN

Jaipur
RAJASTHAN
302002
India 
Phone  9314502834  
Fax    
Email  gpawankumar@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (RAJASTHAN) INDIA 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace, Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJASTHAN) INDIA  
Type of Sponsor  Government medical college 
 
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 
Prof Dr Sanjeev Sharma  National Institute of Ayurveda  OPD No 1, Department of Shalya Tantra, Ground floor, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJASTHAN) INDIA
Jaipur
RAJASTHAN 
09418079691

profsanjeevhp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda Madhav Vilas Palace, Amer Road, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guduchi Ghana Vati  Each Guduchi Ghana Vati contains Guduchi Ghana (Tinospora cordifolia) 500 mg with preservatives and excipients Dosage and Treatment Duration: 2 tablets twice daily orally after meals with water for 45 days  
Comparator Agent  NIL  Dosage and Treatment Duration: Subjects in this group will not be given any medicine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Healthy, Male or Female subjects between the age group of 18 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring or treatment.
2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
 
 
ExclusionCriteria 
Details  1. Pregnant and Lactating females
2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study
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 and 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 3 months prior to screening in the present study.
7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparative assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 days   (day-5, day 0, day-15, day-30, day-45)  
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparative assessment of incidence of other non COVID-19 infections in both the groups
2. Comparative assessment of severity of COVID-19 in both the groups.
3. Comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, ICU admission, Ventilator support and mortality rate.
4. Global assessment of overall change as per the investigator
5. Safety assessment by evaluation of occurrence of AE/SAE
 
(day-5, day 0, day-15, day-30, day-45)  
 
Target Sample Size   Total Sample Size="12000"
Sample Size from India="12000" 
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)   03/06/2020 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET DONE 
Brief Summary   It is an open label, multi centric, randomized, comparative, prospective, interventional community based clinical study to evaluate safety and efficacy of Guduchi Ghana Vati as a preventive remedy on healthy individuals in pandemic of COVID-19. The trial will be completed in 12000 subjects in 6 centers across India. Subjects from group A will be given Guduchi Ghana Vati in a dose of two tablets twice daily orally after meals with water for 45 days. Subjects from group B will not be given any intervention. The primary objectives of the study will be comparative assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 days. Secondary objectives will be comparative assessment of incidence of other non COVID-19 infections in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 days, comparative assessment of severity of COVID-19 (when it occurs) in subjects taking GUDUCHI GHANA VATI and those not taking it. Severity will be graded as per the attached ordinal scale for clinical improvement of COVID-19 published by WHO, comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, number of subjects requiring ICU admission and number of subjects requiring Ventilator support and mortality rate, global assessment of overall change as per the investigator and safety assessment by evaluation of occurrence of AE/SAE on day-5, day 0, day-15, day-30 and day-45.   
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