| CTRI Number |
CTRI/2024/10/074942 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vulvovaginal Candidiasis- Spot diagnosis and Novel treatment modality |
|
Scientific Title of Study
|
Development Of a Novel Point-Of-Care- Testing Device For Rapid Diagnosis And Evaluation Of In-Vitro Therapeutic Potential Of IgY antibody For Vulvovginal Candidiasis At a Tertiary Care Hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEKSHA P |
| Designation |
PhD Research Scholar |
| Affiliation |
SRM Medical college |
| Address |
SRM Medical College Hospital And Research Centre
Potheri
Chengalpattu
Tamil Nadu 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962069236 |
| Fax |
|
| Email |
deeku2462000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajeetha KumariR |
| Designation |
Professor |
| Affiliation |
SRM Medical college Hospital and Research Centre |
| Address |
SRM Medical College Hospital And Research Centre
Potheri
Chengalpattu
Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940170195 |
| Fax |
|
| Email |
sajeethaprabhakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajeetha KumariR |
| Designation |
Professor |
| Affiliation |
SRM Medical college Hospital and Research Centre |
| Address |
SRM Medical College Hospital And Research Centre
Potheri
Chengalpattu
Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940170195 |
| Fax |
|
| Email |
sajeethaprabhakar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpet district
pincode 603203
Tamil nadu
India |
|
|
Primary Sponsor
|
| Name |
Deeksha p |
| Address |
SRM Medical College Hospital And Research
Centre, SRM Nagar, Potheri, Chengalpattu,
Tamil Nadu 603203. |
| 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 |
| DrSajeetha KumariR |
SRM Medical college Hospital and Research Centre |
Department of Obstetrics & Gynecology, Room No 12, SRM Medical College Hospital And Research
Centre, SRM Nagar, Potheri, Chengalpattu,
Tamil Nadu 603203.
Kancheepuram
TAMIL NADU |
9940170195
sajeethaprabhakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
The study includes Candida isolates from vaginal swabs of sexually active women aged above 18 years from Obstetrics and Gynaecology that are routinely sent to the Microbiology laboratory.
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years.
Patients on any antifungal therapy 6 weeks prior to sample collection were excluded from the study
Patients other than Candida infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Novel point of care testing device based on the principle of lateral flow immunoassay and colorimetric method to diagnose vulvovaginal candidiasis rapidly and accurately will be developed
|
October 2024- March 2026
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Therapeutic potential of IgY antibodies to inhibit biofilm formation OF DRUG RESISTANT Candida species in-vitro will be identified
|
January 2025-March 2026 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Aim: The aim of the study is to develop novel point of care testing device to diagnose vulvovaginal candidiasis and evaluate the therapeutic approach of IgY against drug- resistant Candida species. Objective: •To evaluate the enzymatic activity of Candida species by colorimetric method •To extract the Immunoglobulin Y (IgY) from Hen’s egg yolk by Polyethylene glycol precipitation method •To evaluate the potential activity of IgY against Candida biofilm produced by drug resistant Candida species by MTT assay (tetrazolium salt assay) |