| CTRI Number |
CTRI/2022/06/043268 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess impact of Covid-19 and Ayurveda appropriate behavior on Covid-19 infection rate
|
|
Scientific Title of Study
|
Study to assess the impact of Covid appropriate cum Ayurveda Appropriate behavior on incidence of infection: A prospective cohort based approach |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Tanuja Manoj Nesari |
| Designation |
Director |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda,
Sarita Vihar, New Delhi-110076
Gautam Puri, Sarita Vihar, Mathura Road,
New Delhi-110076
South West
DELHI
110076
India |
| Phone |
9958817148 |
| Fax |
011-29948660 |
| Email |
tnesari@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Research Advisor and Biostatistician |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Division of Translational Research and Biostatistics
All India Institute of Ayurveda
Gautam Puri
Sarita Vihar
New Delhi 110076
Mathura Road
South West
DELHI
110076
India |
| Phone |
7300801298 |
| Fax |
01129948660 |
| Email |
dranil250158@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Research Advisor and Biostatistician |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda
Gautam Puri
Sarita Vihar
New Delhi 110076
All India Institute of Ayurveda
Gautam Puri
Sarita Vihar
New Delhi 110076
South West
DELHI
110076
India |
| Phone |
7300801298 |
| Fax |
01129948660 |
| Email |
dranil250158@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda
Sarita Vihar New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda AIIA |
| Address |
AIIA
Sarita Vihar New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ministry of AYUSH |
AYUSH Bhawan, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar |
OPD/Covid vaccination centre, All India Institute of Ayurveda |
Division of Translational Research and Biostatistics,
Room# 313A,Gautam Puri,
Mathura Road, New Delhi
South
DELHI |
7300801298
011-29948660
dranil250158@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Might have taken Covid Vaccine but not a condition for inclusion |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Subjects coming for vaccination at AIIA |
|
| ExclusionCriteria |
| Details |
Age less than 15 or more than 65 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Covid-19 and ayurveda appropriate behavior and its impact on incidence of Covid-19 |
Assessment of Covid-19 and ayurveda appropriate behavior and its impact on Covid-19 incidence during 12 months follow up of cohort |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Extent of Covid-19 appropriate and Ayurveda appropriate behavor |
18 months |
|
|
Target Sample Size
|
Total Sample Size="3583"
Sample Size from India="3583"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study would be published after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response (Others) - observational data
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - referencing and quoting, comparison, generalization
- By what mechanism will data be made available?
Response - Proposals should be directed to [tnesari@hotmail.com].
- For how long will this data be available start date provided 02-10-2023 and end date provided 02-10-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to find out the extent of Covid-19 appropriate behavior and Ayurveda appropriate behavior among aged15 to 65 and find the impact of such practices on the covid-19 incidence. It is assumed that about 20% persons might have been practicing such protective behaviour regularly. So later analysis would be done using Group 1 (Covid-19 appropriate and Ayurveda appropriate behavior regularly) vs Group 2 (without such protective practices) |