| CTRI Number |
CTRI/2025/04/085675 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Smart hygiene solutions to support health tracking |
|
Scientific Title of Study
|
Development of Smart Hygiene Products for Multimodal Detection of Pathological and Biochemical Markers |
| 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 Naresh Kumar Mani |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Biotechnology
Academic Block 2
Manipal Institute of Technology
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8110028989 |
| Fax |
|
| Email |
naresh.mani@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar Mani |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Biotechnology
Academic Block 2
Manipal Institute of Technology
Manipal
KARNATAKA
576104
India |
| Phone |
8110028989 |
| Fax |
|
| Email |
naresh.mani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Kumar Mani |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Biotechnology
Academic Block 2
Manipal Institute of Technology
Manipal
KARNATAKA
576104
India |
| Phone |
8110028989 |
| Fax |
|
| Email |
naresh.mani@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal and Kasturba Medical College, Manipal Academy of Higher Education, Manipal,
Madhav Nagar, Manipal, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Reckitt Benckiser (India) Pvt. Ltd. |
| Address |
Reckitt Benckiser (India) Pvt. Ltd.
Plot No 48
Sector-32
Institutional area
Gurugram
Haryana 122001 |
| Type of Sponsor |
Other [Consumer goods company that manufactures and sells health, hygiene, and nutrition products] |
|
|
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 Naresh Kumar Mani |
Manipal Institute of Technology, Manipal,Kasturba Medical College and Kasturba Hospital, Manipal |
Department of Biotechnology, Manipal Institute of Technology, Manipal, Department of Obstetrics and Gynaecology,
Kasturba Medical College, Manipal, Department of Microbiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
8110028989
naresh.mani@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Any Healthy individuals or Patients without Vaginal and Urinary tract infection |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, (2) ICD-10 Condition: B374||Candidiasis of other urogenital sites, (3) ICD-10 Condition: B373||Candidiasis of vulva and vagina, (4) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, (5) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional diagnosis (Gold standard method) |
Conventional microbial culture will be performed for the vaginal swab and urine samples collected from patients with the vaginal and/or urinary tract infection and healthy individuals or patients without the infection to confirm the results obtained with the developed diagnostic device and compare the results for evaluation of the diagnostic accuracy of the device. |
| Intervention |
Developed diagnostic device |
The developed diagnostic device will be validated with vaginal swab and urine samples from Patients with the vaginal and/or urinary tract infection and healthy individuals or patients without the infection to check for true positive, false positive and false negative results. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Control group:
Inclusion criteria: Any Healthy individuals/Patients without Vaginal and Urinary tract infection visiting
the OBG department, Age group 20-50.
Patient group:
Inclusion criteria: Patients with vaginal infection and/or urinary tract infection, Age group 20-50. |
|
| ExclusionCriteria |
| Details |
Control group:
Exclusion criteria: Pregnant women, Vulnerable group, Patients who recently consumed antibiotics
and antifungals, Patients having viral infections, symptoms of jaundice, hepatitis, HIV, Leptospira,
Chyluria etc.
Patient group:
Exclusion criteria: Pregnant women, Vulnerable group, Patients who recently consumed antibiotics
and antifungals, Patients having viral infections, symptoms of jaundice, hepatitis, HIV, Leptospira,
Chyluria etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The developed diagnostic platform will be tested for diagnostic accuracy in
terms of sensitivity, specificity and other parameters using the clinical vaginal swab and urine samples, and compared with the
Gold standard method i.e. microbial culture. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/05/2025 |
| 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="0"
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
|
- The primary purpose of the study is to test our developed diagnostic device for the detection of vaginal infection and urinary tract infection in women. 25 patients with vaginal infection and/or urinary tract infection will be recruited for the study. 25 healthy individuals or patients without vaginal and urinary tract infection will be recruited as the control group. - 50 vaginal swabs (2 vaginal swabs per patient) will be collected from 25 healthy individuals by the concerned physician or trained personnel in the Department of Obstetrics and Gynaecology, Kasturba Medical College and Kasturba Hospital, Manipal. 25 urine samples (2 urine containers per patient) will be collected from the same 25 healthy individuals by the concerned trained personnel in the Central Collection Centre, Kasturba Hospital, Manipal. - 50 vaginal swabs (2 vaginal swabs per patient) will be collected from 25 patients with vaginal infection and/or urinary tract infection by the concerned physician or trained personnel in the Department of Obstetrics and Gynaecology, Kasturba Medical College and Kasturba Hospital, Manipal. 25 urine samples (2 urine containers per patient) will be collected from the same 25 patients with vaginal infection and/or urinary tract infection by the concerned trained personnel in the Central Collection Centre, Kasturba Medical College and Kasturba Hospital, Manipal.
- One sample of vaginal swab and one urine container collected per patient or healthy individual will be sent to the Department of Microbiology, Kasturba Medical College and Kasturba Hospital, Manipal for conventional testing i.e. microbial culture following the standard protocol of the hospital.
- The remaining one sample of vaginal swab and one urine container per patient or healthy individual will be used to validate the developed diagnostic platform for the detection of vaginal and urinary infection biomarkers and pathogens in Department of Biotechnology, Manipal Institute of Technology, Manipal.
- Anonymized samples will be provided by the concerned Physician for the study.
- The consent from the patients will be taken by the concerned Physician or trained personnel in the Department of OBG for sample collection.
- Basic patient data including only age and any secondary health condition (such as Diabetes or other condition acting as a contributing factor to the infection) will be collected with permission from the concerned Physician.
- The results obtained from the developed device will not be utilized/ will not interfere with the patient intervention. The treatment to the patient if any will be only based on the diagnosis by the concerned Physician and conventional testing performed in the hospital.
- The developed diagnostic platform will be tested for diagnostic accuracy in terms of sensitivity, specificity and other parameters using the clinical samples and compared with the Gold standard method i.e. microbial culture. |