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CTRI Number  CTRI/2020/05/025275 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 21/06/2020
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)  Open to Recruitment 
Publication Details
Modification(s)  
NIL 
Brief Summary  

The ingredients in Chyawanprash promote healthy muscle mass by supporting protein synthesis and the absorption of nutrients. Chyawaprash’s ability to bolster the immune system and remove damaging toxins and free radicals, lends itself to supporting the general strength and energy of the body. It supports healthy muscle mass and tones all the tissues of the body.

Health workers are at the front line of COVID 19 outbreak response and as such are exposed to hazards that put them at risk of infection. In spite of use of PPE and hand sanitizers/handrubs and other preventive aspects, morbidity among exposed health care workers are much more than that of general Public and hence this study was conceived.

 

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