| CTRI Number |
CTRI/2025/11/097918 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Diabetes Study Among Female Sex Workers in Belagavi District" |
|
Scientific Title of Study
|
Prevalence of Diabetes Mellitus among registered female sex workers (FSWs) in Belagavi, Karnataka, India: A cross-sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja PR |
| Designation |
Student |
| Affiliation |
Departmet of public health,JNMC, KAHER, Belagavi |
| Address |
Departmet of public health,JNMC, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8197071541 |
| Fax |
|
| Email |
pr6072835@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashwini Narasannavar |
| Designation |
Associate Professor |
| Affiliation |
Departmet of public health,JNMC, KAHER, Belagavi |
| Address |
Departmet of public health,JNMC, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844992004 |
| Fax |
|
| Email |
drashwinimph2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja PR |
| Designation |
Student |
| Affiliation |
Departmet of public health,JNMC, KAHER, Belagavi |
| Address |
Departmet of public health,JNMC, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8197071541 |
| Fax |
|
| Email |
pr6072835@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POOJA PR |
| Address |
Department of Public Health, JNMC, KAHER, BELAGAVI, 590010 |
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| Pooja PR |
BIRDS NGO |
TI NAME : BIRDS KSAPS FSW TI BELAGAVI
ADDRESS. : B B Desai building Shivaji Nagar 3rd cross Belgavi
Pincode: 590016
Belgaum
KARNATAKA |
8197071541
pr6072835@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes Mellitus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female sex workers aged 18 years or older, Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
•Pregnant women, due to altered glycemic thresholds.
•Those who are severely ill or unable to undergo the study procedures at the time of recruitment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of diabetes mellitus among registered female sex workers in Belagavi |
one point in time or single time-point only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association between socio demographic variables & To assess the economic burden of diabetes mellitus & existing illness among sex workers |
one point in time or single timepoint only |
|
|
Target Sample Size
|
Total Sample Size="306"
Sample Size from India="306"
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)
|
29/12/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to estimate the prevalence of diabetes mellitus among female workers and to explore the socio-demographic factors influencing the cause of DM. This study also seeks to assess the economic burden of DM. Findings are expected to fill a critical data gap and inform inclusive, evidence-based public health interventions tailored to this underserved population |