CTRI Number	CTRI/2020/05/025166 [Registered on: 14/05/2020] Trial Registered Prospectively
Last Modified On:	13/05/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Drug Ayurveda Preventive
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Study of ASHWAGANDHA TABLET on healthy individuals to prevent covid 19
Scientific Title of Study Modification(s)	Observational Study of ASHWAGANDHA 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
Secondary IDs if Any	Secondary ID  Registry  not applicable  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr C Muralikrishna  Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada. Krishna ANDHRA PRADESH 520015 India  Phone  9492030564   Fax     Email  mkchagamreddy@gmail.com
Details Contact Person Scientific Query	Name  Dr C Muralikrishna  Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada. Krishna ANDHRA PRADESH 520015 India  Phone  9492030564   Fax     Email  mkchagamreddy@gmail.com
Details Contact Person Public Query	Name  Dr C Muralikrishna  Address  Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada. Krishna ANDHRA PRADESH 520015 India  Phone  9492030564   Fax     Email  mkchagamreddy@gmail.com
Source of Monetary or Material Support	Ministry Of Ayush , Government of India
Primary Sponsor	Name  Ministry of Ayush Government of India  Address  MINISTRY OF AYUSH AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  nil  nil
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Savita Poshatti Gopod  Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada   Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada Krishna   9177777631 savitagopod18@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  Ashwagandha tablet  Ashwagandha tablet (250mg ) two tablet 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 from 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
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	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Primary outcome parameter: 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 and 45th day
Secondary Outcome	Outcome  TimePoints  1. Comparative assessment of severity of Covid-19 infection in subjects taking ASHWAGANDHA 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"
Phase of Trial Modification(s)	Phase 2/ Phase 3
Date of First Enrollment (India)	19/05/2020
Date of First Enrollment (Global)	No Date Specified
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 Modification(s)	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.Ashwagandhha is Rasayana drug which improves immunity. In This study will give Ashwagandha tab 500mg twice daily for one month to healty 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 outcome    Comparative assessment of severity of Covid-19 infection in subjects taking ASHWAGANDHA 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