CTRI Number	CTRI/2020/05/025275 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On:	09/10/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Role of Chyawanprash in the prevention of COVID-19 in health care workers
Scientific Title of Study	Evaluation of protective potential of an Ayurvedic Rasayan (Chyawanprash) in the prevention of COVID-19 among Health Care Personnel – An open label, prospective Randomized controlled parallel group 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 Arun Gupta  Address  CBPACS, Khera Dabar, New Delhi 110073 Room no 142 Panchkarma Department CBPACS, Khera Dabar, New Delhi South West DELHI 110073 India  Phone  9999155377   Fax     Email  arun24@hotmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Arun Gupta  Address  CBPACS, Khera Dabar, New Delhi 110073 Room no 142 Panchkarma Department CBPACS, Khera Dabar, New Delhi South West DELHI 110073 India  Phone  9999155377   Fax     Email  arun24@hotmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Arun Gupta  Address  CBPACS, Khera Dabar, New Delhi 110073 Room no 142 Panchkarma Department CBPACS, Khera Dabar, New Delhi 110073 South West DELHI 110073 India  Phone  9999155377   Fax     Email  arun24@hotmail.com
Source of Monetary or Material Support	CCRAS, Janakpuri, New Delhi
Primary Sponsor	Name  CCRAS New Delhi  Address  61-65, opp D Block, Janakpuri, Institutional area, Janakpuri, New Delhi 110058  Type of Sponsor  Research institution
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  Prof Dr Vidula Gujjarwar  Ch. Brahm Prakash Ayurved Charak Sansthan  Room no 142 Panchkarma Department CBPACS Khera Dabar New Delhi South West   9990174348 cbpayurved@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Ch. Brahm Prakash Ayurved Charak Sansthan, New Delhi  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  healthcare staff dealing with COVID-19, without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases.
Intervention / Comparator Agent	Type  Name  Details  Intervention  Ayurveda Rasayana along with conventional guidelines for health care workers.  Chyawanprash-12 g twice daily. Dosage form : Avaleha (Jam like paste). Route of Administration : Oral. Time of Administration :Twice in a day- On empty stomach in the morning at least 1 hour before breakfast and at night two hours after dinner Anupana : Warm water. Duration of therapy : 1 month.   Comparator Agent  Conventional guidelines for health care workers as per the WHO.  Conventional guidelines for health care workers as per the WHO.
Inclusion Criteria Modification(s)	Age From  25.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1) All healthcare professionals and staff of age group between 25 to 60 years willing to participate, negative for SARS- Cov-2 at screening,(tested by rt-PCR) without co-morbid condition
ExclusionCriteria	Details  1) Pregnant and lactating females. 2) Immune compromised and co morbid condition cases. 3)Laboratory confirmed COVID-19 with or without symptoms 4)Known allergy to any of the medications used in this trial. 5) Subjects who are taking any other medicine as prophylaxis such as HCQ.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome Modification(s)	Outcome  TimePoints  Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab   baseline Day 30
Secondary Outcome Modification(s)	Outcome  TimePoints  Safety profile of the intervention as estimated by LFT, KFT and other haematological & biochemical investigations. Presence or absence of AE/ADR. Number of participants who developed any infective diseases during the trial period (bacterial /viral/ fungal / etc.) and percentage of participants with Upper respiratory tract illness during the period.   baseline Day 7 Day 15 Day 30
Target Sample Size	Total Sample Size="200" Sample Size from India="200"
Phase of Trial	Phase 3
Date of First Enrollment (India)	30/05/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	NIL
Brief Summary Modification(s)	It was a prospective, controlled, prophylaxis, interventional randomized controlled parallel group study which was conducted at Chaudhary Brahm Prakash Ayurved Charak Sansthan (CBPACS), Khera Dabar, New Delhi on 200 healthcare workers working in COVID ward or COVID hospital. The healthcare workers are divided in two groups (100 Participants in each group). Healthcare professionals and staff of any age group which were negative for SARS- Cov-2 at screening, (tested by RT-PCR), without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases were enrolled in the study. Group 1 participants were following standard preventive regimen and group 2 participants were given Ayurveda Rasayana (Chyawanprash) along with standard preventive regimen. Ayurveda Rasayana (Chyawanprash) was given in 12 gm twice daily dose, orally on empty stomach in the morning at least 1 hour before breakfast and at night two hours after dinner with warm water for 1 month. A total of 204 patients were screened and 199 were enrolled in the study. 193 subjects completed the study and 6 subjects dropped out from the study. 99 subjects were enrolled in group 1 and 100 subjects were enrolled in group 2. In group 1, 95 subjects completed the study and in group 2; 98 subjects completed the study. No adverse event was recorded in the study.