| CTRI Number |
CTRI/2020/07/026925 [Registered on: 30/07/2020] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
to see the effect of twakadi(tea made up of dalcheeni, tulasi pepper, clove, etc)tea on police worker who have a duty in covid 19 pandemic |
|
Scientific Title of Study
|
Clinical trials to evaluate prophylactic action of Twakadi herbal tea in police professionals working in COVID19 pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogini Kulkarni |
| Designation |
Professor |
| Affiliation |
carc akurdi |
| Address |
Department of Research college of Ayurved and Research Center, Akurdi
ground floor, shalyatantra department, ayurved rugnalay and sterling multispeciality hospital, nigdi pradhikaran, sector 26 near bhel chowk pune 411044
Pune
MAHARASHTRA
dr Yogini Kulkarni
India |
| Phone |
9822419089 |
| Fax |
|
| Email |
dryoginik01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogini Kulkarni |
| Designation |
Professor |
| Affiliation |
CARC Akurdi |
| Address |
Department of Research College of Ayurved and Researche center, Akurdi
Pune
MAHARASHTRA
dr Yogini Kulkarni
India |
| Phone |
9822419089 |
| Fax |
|
| Email |
dryoginik01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogini Kulkarni |
| Designation |
Professor |
| Affiliation |
carc akurdi |
| Address |
Department of research College Of Ayurved and Research center Akurdi
Pune
MAHARASHTRA
dr Yogini Kulkarni
India |
| Phone |
09822419089 |
| Fax |
|
| Email |
dryoginik01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sterling Multispeciality Hospital and Ayurved Rugnalay |
|
|
Primary Sponsor
|
| Name |
Sterling Multispeciality Hosptal and Ayurved Rugnalay |
| Address |
Sector 27 Nigdi Pradhikaran near Bhel chowk Nigdi Pune 411044 |
| 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 |
| Dr Yogini Kulkarni |
Sterling Multispeciality Hospital and Ayurved Rugnalay |
Ground floor, Shalyatantra Department, Ayurved Rugnalay and Sterling Multispeciality Hospital, Nigdi Pradhikaran, sector 26 near Bhel Chowk pune 411044
Pune
MAHARASHTRA |
9822419089
dryoginik01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Police professionals having age above 25 irrespective of gender |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Twakadi herbal tea |
procurement of all herbs(tulasi, Pippali, yashtimadhu, Ginger, Draksha, Dalchini) from authentic sources,(1 cup) authentication of herbs by botanical institutes, standarization of all course powder as per API analysis, tea bag preparation |
| Comparator Agent |
use of mask
social distancing.
|
preventive measures regarding covid 19 |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
police professionals working in covid 19 pandemic having age above 25 years irrespective of gender.
negative for covid 19.
who are willing to provide signed informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number Of Participants With Laboratory Confirmed COVID-19 positivity in 14 days |
Number of participants with laboratory confirmed COVID-19 positivity in 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
inflammatory markers (CRP) at the end of the baseline and end of the treatment.
ADR/AE recorded
number of partcipants who suffered with any type of infective disease during the trial period |
- |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Indicating overall aims of the research importance of the objectives and their application in the context of the priority area set out in the application form. As per ayurveda it is mentioned that those who have some doshvaigunya or suffered with other diseases as diabetes, heart diseases, and hypertension are more prone to viral infectious diseases. so this study is aimed at to compare the incidence of covid 19 pandemic between the test and control group. So the prophlactic action of twakadi herbal tea in police professionals who are having age more than 25 yeara will be evalueted by the incidence of the disease. If the individuals get positive for covid 19 if any of group will be evalueted for severity of the symptoms. |