| CTRI Number |
CTRI/2021/03/031668 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Adi five layered designer cotton face mask with filter |
|
Scientific Title of Study
|
Use of five layered Adi’s cotton face mask with a filter and its commercial application during and after Covid-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Department of Orthopaedics
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
adityagrawal83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Department of Orthopaedics
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
adityagrawal83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Department of Orthopaedics
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
adityagrawal83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Aditya Agrawal
Associate Professor
Department of Orthopaedics
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Aditya K Agrawal |
| Address |
Department of Orthopaedics
Srimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aditya Agrawal |
Department of Orthopaedics
SBKSMIRC
Sumandeep Vidyapeeth An Institution to be Deemed |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditya Agrawal |
Dhiraj Hospital |
Department of Microbiology
SBKSMIRC
Sumandeep Vidyapeeth An Institution to be Deemed
Piparia
Vadodara
Vadodara
GUJARAT |
7567889991
adityagrawal83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Residents of Department of orthopaedics |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adis 5 layered cotton face mask with filter |
The Adi’s five layered cotton face mask is made primarily by four folds of a gent’s large size 15†x 6†handkerchief. The four straps on the sides of the rectangular face mask are also made of cotton fabric. There are two layers in the front and one layer in the back stitched in all sides except one on the right side. In between, we can put a double layered folded tissue paper, HEPA filter or poly-microurathene sponge material between the second and third layer of the mask. |
| Comparator Agent |
N95 mask |
was used as one of the comparator |
| Comparator Agent |
no mask |
control |
| Comparator Agent |
surgical mask |
on of the comparator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants of age 18-40 years with no co-morbidities |
|
| ExclusionCriteria |
| Details |
participants who were not willing for the study or anyone having cough, cold or fever |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adis face mask is equivalent to N-95 face mask |
48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cost effective, repeated use |
approx 2 yrs |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
17/02/2021 |
| 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="0"
Days="15" |
|
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)?
Response - NO
|
|
Brief Summary
|
Introduction: COVID 19 is a global pandemic which has led to crisis in supply of essential goods and services, personal protective equipments including face masks. Aim: To Compare Adi’s five layered cotton face mask with N 95 mask with regards to cost and efficacy. Material and Methods: After IEC, sample size of 10 was randomly selected. In a closed chamber made up of glass, three plates of blood agar (BA), chocolate agar (ChocA) and MacConkey agar (MCA) were kept and at four different times, first without mask (Group D), second with N95 mask (Group N), third with surgical mask (Group S) and lastly with Adi’s face mask (group A). Participant at first coughed 3 times then sang for 3 minutes and lastly spoke for 2 minutes for each group. Plates were observed for growth after 24 hours. Inclusion criteria: Age 18-40 yrs of either sex, with no co-morbidities. Exclusion criteria: Anyone having cough, cold or fever. Results: In Group A, one pink pin point colony was seen on MCA, in Group N, one pink pin point colony was seen. Conclusion: Adi’s mask is almost equivalent to wearing N-95 mask. It is easy to use, innovative, simple, scientific and cost effective. |