FULL DETAILS (Read-only)

CTRI Number  CTRI/2020/05/025213 [Registered on: 15/05/2020] Trial Registered Prospectively
Last Modified On: 15/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Trial 
Public Title of Study   Ayurveda formulation for COVID-19 prevention 
Scientific Title of Study   Impact of Ayurvedic intervention (Guduchighan vati)in prevention of COVID-19 infection in containment areas of Himachal Pradesh-A community based study 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Kavita Vyas 
Address  Regional Ayurveda research institute for nutritional disorders, Ground floor, Room number 3 Jaral Pandoh Near BBMB Hospital

Mandi
HIMACHAL PRADESH
175124
India 
Phone  8219339718  
Fax    
Email  kavitakrishu@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Kavita Vyas 
Address  Ground floor Room number 3 Regional Ayurveda research institute for nutritional disorders Jaral Pandoh District Mandi NEAR BBMB HOSPITAL

Mandi
HIMACHAL PRADESH
175124
India 
Phone  8219339718  
Fax    
Email  kavitakrishu@gmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Kavita Vyas 
Address  Ground floor Room number 3 Regional Ayurveda research institute for nutritional disorders Jaral Pandoh District Mandi

Mandi
HIMACHAL PRADESH
175124
India 
Phone  8219339718  
Fax    
Email  kavitakrishu@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Central Council for research in Ayurvedic Sciences 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 ( India ) 
Type of Sponsor  Other [research organisation ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavita Vyas  Regional Ayurveda research institute for Nutritional Disorders  Department of central council for research in Ayurvedic Sciences, Jaral Pandoh 175124
Mandi
 
9888552911

kavitakrishu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RARIND IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of COVID-19 in containment zones 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guduchi ghan vati  drug to be given in dose of 500mg BD with lukewarm water before meals for 30 days 
Comparator Agent  Not applicable  not applicable 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Residents of the identified containment zones, marked by government of Himachal Pradesh for high risk of COVID 19
Willing to take study medication,
Provides written informed consent prior to initiation of study Procedures.
 
 
ExclusionCriteria 
Details  Persons already treated with study drug during the last 30 days;
Pregnant and lactating females and those who have a pregnancy plan.
Participants with any immunosuppressive medication or in an immune Compromised state or hematological disease.
Laboratory confirmed COVID-19 cases with or without symptoms.
Known allergy to the medication used in this trial.
Not willing to participate in the study.
Any other criteria, as per the investigator would jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Incidence of COVID 19 positive cases as confirmed by hospital by standard investigation, real time polymerase chain reaction test among Ayurveda users.   At baseline,1 week, 2 weeks, 3 weeks, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Incidence of severe COVID 19 positive cases (admitted in hospital and requiring ventilation and/or multi-organ failure as reported by hospital) among Ayurveda users.
2) Incidence of mortality due to COVID 19 among Ayurveda users as compared to non-users.
3) Incidence of any other ailment like cough, fever, sore throat etc. (as per questionnaire annexed) during this study.
4) Change in appetite, bowel habit, sleep among the users
 
7th, 14th, 22nd and 30th day after first visit  
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/05/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Outcomes of the study will be published in the reputed journal of the council, Journal of Research in Ayurvedic Sciences JRAS 
Brief Summary  

Ministry of AYUSH has released certain guidelines for prevention of COVID through certain common kitchen spices, herbs and practices.

In order to capture the effectiveness of such preventive measures, guidelines and Ayurveda advocacies, a prospective intervention community study is planned to capture the relative risk and incidence of COVID 19 among Ayurveda users.

The study will be conducted as an open label prospective community-based study. It is designed to capture the desired objectives of the study, based on pre-defined close ended and certain open-ended questions to collect the data.

 

Close