| 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 Study |
|
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
|
|
|
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
|
|
|
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
Modification(s)
|
| 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
Modification(s)
|
| 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
|
