| CTRI Number |
CTRI/2020/06/025561 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
13/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Open label Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Ayurvedic medicine in the Prophylaxis for COVID-19 of AYUSH healthcare workers , Dept of AYUSH, TS & CCRAS- NIIMH, Hyderabad.
|
|
Scientific Title of Study
|
Prospective open label observational study on the effect of AYUSH-64, Samshamani vati & Chyavanprash- (Ayurvedic Raksha Kit-l) as Prophylactic measure among AYUSH healthcare workers working in the vicinity of COVID -19 facilities. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srikanth Babu Perugu |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
|
| Address |
Department of Kayachikitsa,
Dr. B.R.K.R. Government Ayurvedic
College
SR Nagar
Hyderabad-500038
TELANGANA
#101,
district judges quarters ,
road no 10,banjara hills,
hyderabad 500034
Hyderabad
TELANGANA
500038
India |
| Phone |
9849463878 |
| Fax |
|
| Email |
drperugu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanth Babu Perugu |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
|
| Address |
Department of Kayachikitsa, Dr. B.R.K.R. Government Ayurvedic
College SR Nagar Hyderabad
Hyderabad
TELANGANA
#101, district judges quarters, road no, 10, banjara hills, hyderabad-500034
Hyderabad
TELANGANA
500038
India |
| Phone |
9849463878 |
| Fax |
|
| Email |
drperugu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srikanth Babu Perugu |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
|
| Address |
Department of Kayachikitsa, Dr. B.R.K.R. Government Ayurvedic
College SR Nagar Hyderabad
Hyderabad
TELANGANA
#101, district judges quarters,
road no 10,banjara hills, Hyderabad- 500034
Hyderabad
TELANGANA
500038
India |
| Phone |
9849463878 |
| Fax |
|
| Email |
drperugu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of AYUSH Govt. of Telangana– Ayurveda & CCRAS-NIIMH, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Govt of Telangana Ayurveda CCRASNIIMH Hyderabad |
| Address |
Department of Ayush, Opposite passport office, Government Of
Telangana
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPSrikanth Babu |
Dr. B.R.K.R. Government Ayurvedic College |
Department of
Kayachikitsa, SR
Nagar
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9849463878
drperuugu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee CCRAS-NIIMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ayush health workers in vicinity of COVID 19 facility |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RAKSHA KIT-1 |
Chavanprash, 10 grams once aday Samshamani vati 250 mg 2 times a day
& AYUSH 64 500 mg 2 times a day |
| Comparator Agent |
Standard Prophylactic Care |
Standard Prophylactic Care recommended by Government of Telangana Health authorities |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1. AYUSH health care workers working within the facilities of COVID-19 duties.
2. Subjects who are from a community where at least 1 confirmed case is already identified.
3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Pregnant and Lactating females.
2. Known cases of uncontrolled Diabetes and Hypertension.
3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention.
8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparative assessment of occurrence of
COVID-19 infection in healthy volunteers vis
Police personal in community having at least 1
confirmed case already identified with control
arm of Standard Prophylactic Care |
0 day and
40th day
Comparative assessment of occurrence of
COVID-19 infection in healthy
volunteers vis
AYUSH personal in community having at least 1
confirmed case already identified with control
arm of Standard Prophylactic Care |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General health status of those who are taking
Ayurveda preventive medicine. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
in view of the no treatment available for COVID-19 infection as on date, there is a need to investigate the potential of ayurvedic preventive medicine. Classical texts of Ayurveda have emphasized the out break of such pandemics in the name of "Janapadodhwamsa" and narrated a specific preventive protocol. This is an attempt to observe the preventiive role of Ayurveda protocol in ayush personel / Healthy volunteers working in the vicinity of covid-19 facilities. |