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
|
|
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
|
|
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)
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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.
|