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CTRI Number  CTRI/2020/05/025425 [Registered on: 28/05/2020] Trial Registered Prospectively
Last Modified On: 09/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Single Arm Trial 
Public Title of Study   Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel  
Scientific Title of Study   Evaluation of the efficacy of an Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel – An open label single arm prospective 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 Nitin Jindal 
Address  Dept. Of Panchakarama, A & U Tibbia College, Karol Bagh, New Delhi
A & U Tibbia College, Karol Bagh, New Delhi
Central
DELHI
110005
India 
Phone  9354925045  
Fax    
Email  nitjin2005@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr BabitaYadav  
Address  Room No 119 A Central Council for Research in Ayurvedic Sciences, D Block Janakpuri, New Delhi South West DELHI 110058 India
Room No 119 A Central Council for Research in Ayurvedic Sciences, D Block Janakpuri, New Delhi
West
DELHI
110058
India 
Phone  9910171143  
Fax    
Email  drbabitayadav@gmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Shivshankar Rajput  
Address  IPD Building First Floor Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi West DELHI 110026 India
IPD Building First Floor Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi West DELHI 110026 India
West
DELHI
110026
India 
Phone  8460819669  
Fax    
Email  shivshankerdr@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Central Council For Research in Ayurvedic Sciences, Central Council For Research in Ayurvedic Sciences Ministry of AYUSH, Govt. of India, J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri  
 
Primary Sponsor  
Name  Central Council For Research in Ayurvedic Sciences  
Address  J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri  
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 
DR NITIN JINDAL  Dept. of Panchakarma, A & U Tibbia College & Hospital,  Ajmal Khan Road, Karol Bagh, New Delhi
Central
 
0981176550

nitjin2005@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, A & U Tibbia College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthcare professionals of A & U Tibbia College & Hospital, Karol Bagh, New Delhi 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Chayapanprash (an Ayurvedic herbal preparation)  Dose: 12 g twice daily. Dosage form : Avaleha. Route of Administration : Oral. Time of Administration : Twice in a day- On empty stomach in the morning at least 1 hour before breakfast and two hours after dinner at night. Anupana : Warm water. Duration of therapy : 30 days.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All healthcare professionals of 20 to 60 years willing to participate, who were negative for SARS- Cov-2 at screening, (tested by RT-PCR), at A & U, Tibbia hospital dealing with COVID-19, with or without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases.
2. Those who are willing to provide signed informed consent.
3. High Risk Group- It includes doctors, nursing staff and other paramedical staff like attendant who are directly looking after and examining COVID patients.
4. Low risk- other faculty members who are present in the institute but not visiting corona ward.
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating females.
2. Known case of Carcinoma lungs, CRF and CHF.
3. Participants with any immunosuppressive medication or in an immune compromised state or hematological disease.
4. Laboratory confirmed COVID-19 with or without symptoms.
5. DM uncontrolled with medications.
6. 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
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Outcome  TimePoints 
1. Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab.   Assessment on baseline and at the end of study that is 30th day  
 
Secondary Outcome
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Outcome  TimePoints 
1. Safety profile of the intervention as estimated by LFT, KFT and other hematological & biochemical investigations.
 
Time frame : 30 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   02/06/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Under Process 
Brief Summary
Modification(s)  

Abstract-

Background- The infection due to SARS-Cov-2 was declared as a pandemic disease COVID-19 on 11th March, 2020 by WHO. High fatality rate envisaging many healthcare workers have been observed in ealry days of pandemic due to limited knwoledge about the pathology of the disease. In view of no substantial treatment or vaccination, prevention is still considered as best remedy.  Chyawanprash is a popular Rasayan medicine used for influenza like illnesses (ILI). The study was planned to assess the role of Chyawanprash for prevention of COVID-19 infection and its safety profile.

Methods- It was a single arm prospective interventional study conducted on healthcare workers deputed in COVID Isolation Ward of repurposed hospital. The sample size for this study was of 50 and duration of intervention was 30 days. The study was registered with CTRI vide registration no CTRI/05/2020/5425. Chyawanprash was given in a dose of 12 mgs twice a day i.e. morning and night. The results were assessed on the basis of RTPCR for COVID 19 and relevant biomarkers for safety profile.  

Results –Total 49 participants completed the study of which only 02 were found positive for COVID-19 on completion of study period. During the study period only 02 events of other infection were observed but no serious adverse event was noticed. Chayavanprash was found safe as there were no significant  changes observed in Liver and Kidney functions. 

Conclusion- Chyawanprash is a renowned Rasayan meidicne used since year to prevent ILIs. Considering the current situation of pandemic and overwhelmed healthcare system, the outcome of this pilot study is encouraging in context to a possible safe prophylactic remedy for COVID-19


 

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