CTRI

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CTRI Number

CTRI/2024/01/061314 [Registered on: 10/01/2024] Trial Registered Prospectively

Last Modified On:

18/06/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

To understand the antimicrobial usage among small scale household dairy farms in Udupi Taluk Karnataka

Scientific Title of Study

Antimicrobial usage assessment and the factors associated among small scale household dairy farms in Udupi Taluk Karnataka

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Shwetha
Designation	Master of Public Health Student
Affiliation	Prasanna School of Public Health
Address	Room number 4 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi KARNATAKA 576104 India
Phone	9740373990
Fax
Email	shwethaprabhu0@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Navya Vyas
Designation	Assistant Professor Senior Scale
Affiliation	Prasanna School of Public Health
Address	Room number 51 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi KARNATAKA 576104 India
Phone	9538126121
Fax
Email	navya.vyas@manipal.edu

Details of Contact Person
Public Query

Name	Dr Navya Vyas
Designation	Assistant Professor Senior Scale
Affiliation	Prasanna School of Public Health
Address	Room number 51 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi KARNATAKA 576104 India
Phone	9538126121
Fax
Email	navya.vyas@manipal.edu

Source of Monetary or Material Support

Prasanna School of Public Health

Primary Sponsor

Name	Shwetha
Address	Master of Public Health Student Room number 4 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Pin code 576104
Type of Sponsor	Other [Self funded]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Navya Vyas	Prasanna School of Public Health	Room number 51 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi KARNATAKA	9538126121 navya.vyas@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy population

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Small scale household dairy farmers who supply milk to the milk collection societies Dairy farmers with a minimum of 1 year of experience located in Udupi Taluk and who provide consent to participate in the study Participants age more than 18 years Local veterinarians under Animal Husbandry and Veterinary Services serving the villages from where the small scale household dairy farmers recruited for the study

ExclusionCriteria

Details

Individuals who do not speak or understand the language in which this study is conducted
Farmers whose farms are not within their household area are excluded

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

This study will assess antimicrobial usage and associated factors in small scale household dairy farms
while evaluating animal health management practices among dairy farmers and veterinarians
It will assess the factors of antimicrobial resistance (AMR) in these farms including usage and hygiene practices
Additionally it will help in identifying whether antibiotic residues are present or absent in raw milk samples through test reports obtained from Udupi Dairy
This comprehensive research enhances understanding of antimicrobial use in farming practices and milk safety in small dairy operations

6 months

Secondary Outcome

Outcome	TimePoints
This study will provide valuable insights for policymakers and increase farmer awareness of antimicrobial resistance.	6 months

Target Sample Size

Total Sample Size="340"
Sample Size from India="340"
Final Enrollment numbers achieved (Total)= "335"
Final Enrollment numbers achieved (India)="335"

Phase of Trial

N/A

Date of First Enrollment (India)

15/01/2024

Date of Study Completion (India)

20/03/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

According to WHO, Antimicrobial resistance(AMR), a top ten global health threat, endangers the ability to treat common diseases, causing approximately 4.95 million annual deaths worldwide. India faces a significant challenge with one of the highest rates of AMR in humans and food animals. Antibiotics are frequently sold to farmers without prescriptions. Existing research on antibiotic use and AMR in livestock mainly focuses on large scale farms, leaving a gap in understanding small household dairy farms. This study aims to bridge this gap by assessing the antimicrobial usage patterns, influencing factors and AMR determinants in small scale household dairy farms.