| CTRI Number |
CTRI/2025/08/093683 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
“COMPARING STANDARD TREATMENT AND PROBIOTICS FOR TREATING VAGINAL YEAST INFECTIONS” |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF STANDARD AZOLE THERAPY FOR TREATMENT OF VAGINAL CANDIDAL INFECTION ALONE AND IN COMBINATION WITH PROBIOTICS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhashini |
| Designation |
Postgraduate |
| Affiliation |
SRM medical college and hospital |
| Address |
Department of obstetrics and gynaecology
SRM medical college ,hospital and research centre
Potheri
Kattankulathur
SRM medical college and hospital
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443846272 |
| Fax |
|
| Email |
subhathangaraj080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sajeetha kumari |
| Designation |
Professor |
| Affiliation |
SRM medical college and hospital |
| Address |
SRM medical college and hospital
Mahatma gandhi road
Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940170195 |
| Fax |
|
| Email |
sajeethaprabhakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhashini |
| Designation |
Postgraduate |
| Affiliation |
SRM medical college and hospital |
| Address |
Department of obstetrics and gynaecology
SRM medical college ,hospital and research centre
Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443846272 |
| Fax |
|
| Email |
subhathangaraj080@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM medical college ,hospital and research centre
Potheri
Kattankulathur
Tamilnadu -603203
India
|
|
|
Primary Sponsor
|
| Name |
Subhashini |
| Address |
Department of obstetrics and gynaecology
SRM medical college ,hospital and research centre
Potheri
Kattankulathur
Tamilnadu
India-603203 |
| 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 Subhashini |
SRM medical college, hospital and research centre |
Room no -5
Department of obstetrics and gynaecology
Kancheepuram
TAMIL NADU |
9443846272
subhathangaraj080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluconazole |
200mg per oral stat |
| Intervention |
Microflora |
BD for 28days |
| Comparator Agent |
Placebo |
Calcium tablets 500mg BD for 28days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women in the reproductive age group
Presenting with vaginal discharge or itching or burning vaginal feeling or dysuria or dyspareunia
Evidence of positive candidial species by KOH mount by culture result
Willingness to participate |
|
| ExclusionCriteria |
| Details |
Pregnancy, lactation, use of systemic or intravaginal antibiotic or antifungal agents cursor within the past 2 weeks,
Menstruation during sample collection
Postmenopausal women
Patients who are positive for bacterial vaginosis/trichomoniasis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Look for vaginal discharge, itching, burning vaginal feeling, vaginal ph |
Pretreatment followup, 14th day followup, 28th day followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Presence of candida by culture method |
Pretreatment, 28th day followup |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/09/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Vulvovaginal candidiasis is a fundal infection that affects the vulva and vagina. Aim- to compare the efficacy of standard anole therapy for treatment of vaginal candidiasis alone and in combination with probiotics Objectives- to compare the improvement of symptoms in both study and control groups, the compare the change in vaginal ph in both groups, to compare the culture growth in both the groups |