| CTRI Number |
CTRI/2024/09/074183 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
to diagnose bacterial vaginosis bacterial vaginosis rapid test kit and comparing with pap smear reasults |
|
Scientific Title of Study
|
SENSITIVITY AND SPECIFICITY OF BACTERIAL VAGINOSIS RAPID TEST KIT IN DIAGNOSING BACTERIAL VAGINOSIS: A PROSPECTIVE OBSERVATIONAL 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 |
Dr Katta Sushma |
| Designation |
junior resident (post graduate) |
| Affiliation |
Shri B.M.Patil medical college hospital and research Centre |
| Address |
OBG opd no-2,obg department,Shri B.M.Patil medical college hospital and research Centre,Bangaramma sajjan campus ,solapur road
Bijapur
KARNATAKA
586103
India |
| Phone |
8330943833 |
| Fax |
|
| Email |
sushma.20katta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna M Biradar |
| Designation |
Professor |
| Affiliation |
Shri B.M.Patil medical college hospital and research center |
| Address |
Obg opd NO-2,OBG department
Shri B M patil medical college hospital and reasearch centre,bagaramma sajjan campus,Solapur road
Vijayapura
Pincode-586103
Bijapur
KARNATAKA
586103
India |
| Phone |
7676351153 |
| Fax |
|
| Email |
aruna.biradar@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Katta Sushma |
| Designation |
junior resident (post graduate) |
| Affiliation |
Shri B.M.Patil medical college hospital and research center |
| Address |
OBG opd no-2,OBG Department,Shri B.M.Patil medical college hospital and research Centre,Bangaramma sajjan campus ,solapur road
Bijapur
KARNATAKA
586103
India |
| Phone |
8330943833 |
| Fax |
|
| Email |
sushma.20katta@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG OPD NO-2 ,Shri B.M.Patil medical college Hospital and research center ,Vijayapura,karnataka-586103 |
|
|
Primary Sponsor
|
| Name |
Dr Katta Sushma |
| Address |
Obg Opd no-2,Shri B.M.Patil medical college hospital and research Centre, Vijayapura |
| Type of Sponsor |
Other [SELF] |
|
|
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 Katta Sushma |
Shri B.M.Patil medical college hospital and research centre |
OBG OPD No-2,obg department,Shri B.M.Patil medical college hospital and research centre,vijayapura
Bijapur
KARNATAKA |
8330943833
sushma.20katta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R398||Other symptoms and signs involvingthe genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SENSITIVITY AND SPECIFICITY OF BACTERIAL VAGINOSIS RAPID TEST KIT IN DIAGNOSING BACTERIAL VAGINOSIS: A PROSPECTIVE OBSERVATIONAL STUDY |
BACTERIALVAGINOSIS RAPID TEST KIT |
| Comparator Agent |
SENSITIVITY AND SPECIFICITY OF BACTERIAL VAGINOSIS RAPID TEST KIT IN DIAGNOSING BACTERIAL VAGINOSIS: A PROSPECTIVE OBSERVATIONAL STUDY |
PAP SMEAR |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
White discharge per vagina.
|
|
| ExclusionCriteria |
| Details |
Patients with bleeding per vagina along with white discharge per vagina.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| By this study, if the rapid test kit is proven then this kit will be the more efficient and economical way to diagnose bacterial vaginosis and hence reducing the time duration of diagnosing and treatment |
30 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Helps in rapid diagnosis of bacterial vaginosis infection |
3 days |
|
|
Target Sample Size
|
Total Sample Size="285"
Sample Size from India="285"
Final Enrollment numbers achieved (Total)= "285"
Final Enrollment numbers achieved (India)="285" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/10/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective observational study. All women of age 19 to 45 years of age with complaint of white discharge per vagina and willing to give written and informed consent will be included in the study. A detailed history and examination will be conducted. Per speculum examination will be done and vaginal swab will be taken slowly and sent for analysis. Two samples will be taken, one for BV Kit and the other sample is sent for grams staining. Swab is transferred on to the test area of kit and after 20 seconds under bright light compare the color of test strip with the color card. If the result is between 5-9 then it is diagnosed as bacterial vaginosis. The results of both the samples will be analyzed and results documented. |