| CTRI Number |
CTRI/2017/05/008686 [Registered on: 29/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of two hand cleaning techniques in reducing the germs among sanitation workers in Mangaluru |
|
Scientific Title of Study
|
Efficacy of hand sanitizer in reducing hand bacterial count as compared to liquid soap among sanitation workers in Mangaluru:
A Randomized Controlled Trial |
| Trial Acronym |
EHSAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1192-9080 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Mithra P |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College
Hampankatta, LHH Road
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449243260 |
| Fax |
|
| Email |
ppmithra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Mithra P |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College
Hampankatta, LHH Road
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449243260 |
| Fax |
|
| Email |
ppmithra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Mithra P |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College
Hampankatta, LHH Road
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449243260 |
| Fax |
|
| Email |
ppmithra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Mangaluru |
| Address |
Light house hill Road, Hampankatta,Mangaluru-575001; Karnataka State |
| Type of Sponsor |
Private medical college |
|
|
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 Prasanna Mithra P |
Kasturba Medical College, Mangalore |
Department of Community Medicine,
Light house hill Road,
Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA |
9449243260
ppmithra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human participants who work as sanitation workers in the study area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alcohol based hand sanitizer |
Alcohol based hand sanitizer is known to have effects in reducing the bacterial counts of hand. Its efficacy is being compared with the traditional liquid soap in reducing hand bacterial count |
| Comparator Agent |
Liquid soap |
Liquid soaps also are known to have anti bacterial effects on hand. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All registered sanitation workers in the targeted facilities and giving consent to take part in the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand bacterial count |
Three minutes after the interventions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bacterial morphology |
Three minutes after the interventions |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized control trial is being carried out to assess the efficacy of alcohol based hand sanitizers in bringing down the hand bacterial count as compared to antiseptic soap among sanitation workers in the study area and to study the level of awareness and practices related to hand hygiene among the sanitation workers |