| CTRI Number |
CTRI/2025/02/080109 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Smart Sanitary Pads with Sensors for Autistic Individuals, Newborns, and Bedridden Patients. |
|
Scientific Title of Study
|
Smart bio-compatible membrane sensor for bed-ridden, autistic and neonatal sanitary pads. |
| 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 Jijo Lukose |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01
AB-5
MIT
Manipal Academy of Higher Education
Manipal
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8310284970 |
| Fax |
|
| Email |
jijo.lukose@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jijo Lukose |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01
AB-5
MIT
Manipal Academy of Higher Education
Manipal
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8310284970 |
| Fax |
|
| Email |
jijo.lukose@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jijo Lukose |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01
AB-5
MIT
Manipal Academy of Higher Education
Manipal
Karnataka
India
576104
Udupi
KARNATAKA
576104
India |
| Phone |
8310284970 |
| Fax |
|
| Email |
jijo.lukose@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of science & Technology |
|
|
Primary Sponsor
|
| Name |
Department of science & Technology |
| Address |
Department of Science & Technology
Technology Bhavan
New Mehrauli Road
New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrGanesh Mohan |
Kasturba Medical College, MAHE, Manipal |
Department of Immunohematology and Blood Transfusion, Kasturba Medical College, Manipal, MAHE, Manipal-576104
Udupi
KARNATAKA |
9539788828
ganesh.mohan@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 |
Blood donated from Healthy volunteers in the age group 20 - 50 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Donated blood from healthy volunteers in the age group 20- 50 years. |
|
| ExclusionCriteria |
| Details |
Age group below 20 years and above 50 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of biocompatible and biodegradable sensors designed for cost-effectiveness, ensuring accessibility for low-income communities and widespread adoption. The sensors will feature a user-friendly, portable design, facilitating ease of use and broad applicability. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Providing better support for caregivers,increasing market adoption, & improving health outcomes to empower the community.
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
28/02/2025 |
| 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 sensor addresses challenges faced by autistic people, bedridden individuals, neonates, elderly persons, and those with limited mobility by detecting events such as menstrual flow or soiled diapers. Once an event is identified, the embedded microchip activates and transmits a notification to caregivers or healthcare professionals via cloud-connected platforms, accessible through mobile or web applications. Sanitary pads equipped with this sensor offer an advanced solution for monitoring menstruation and indicating the optimal time for a change. Its biocompatible, non-invasive, and compact design ensures user comfort and safety, making it ideal for neonatal care and continuous sanitation monitoring. This versatile device bridges the gap between health monitoring and caregiving, enabling timely and effective responses across a range of healthcare scenarios. |