| CTRI Number |
CTRI/2024/11/077109 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tracing Plastic Particles: A Detailed Study of Their Presence in Human Urine. |
|
Scientific Title of Study
|
Qualitative and Quantitative Assessment Of Microplastics in Urine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAMODHA ACHARY |
| Designation |
MSc Medical Laboratory Technology (Clinical Biochemistry) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Laboratory Technology, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9535236325 |
| Fax |
|
| Email |
pramodha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saritha Kamath U |
| Designation |
Additional Professor/Head Dept of MLT MCHP, MAHE Manipal |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Medical Laboratory Technology
Manipal College Of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9844344459 |
| Fax |
|
| Email |
saritha.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
PRAMODHA ACHARY |
| Designation |
MSc Medical Laboratory Technology (Clinical Biochemistry) |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Medical Laboratory Technology
Manipal College Of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9535236325 |
| Fax |
|
| Email |
pramodha.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Atomic and Molecular Physics, Manipal Institute of Technology, Manipal , Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal Academy of Higher Education, Manipal, Udupi district, Karnataka, India, 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Shobha U Kamath |
Kasturba Hospital and Kasturba Medical College, Manipal |
Department of Biochemistry, Kasturba Hospital and Kasturba Medical College, MAHE, Manipal, 576104
Udupi
KARNATAKA |
9845865848
Shobha.kamath@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-2 (Student Research)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults between the age range of 18 to 50 Years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Adults |
|
| ExclusionCriteria |
| Details |
Hematuria.
On medications or supplements.
Any diagnosed medical conditions.
No recent microplastic contamination or major surgery history.
Pregnancy or breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Method for estimation of microplastics in urine sample |
At the time of standardization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detection of microplastics in urine in nanogram/ml |
At the time of analysis |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2024 |
| Date of Study Completion (India) |
13/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
De size microplastics in urine sample by applying qualitative and quantitative method, provides insights into the extent of human exposure to microplastics. Microplastics standard will be procured. Based on the molecule structure, a suitable analytical tool will be selected. Microplastic standard will be used to standardize the selected analytical tool. Standardized method will be used for detection of microplastics in urine sample. Participants visiting to collection center for routine Urine Analysis will be approached. Informed consent will be taken from them to use left over Urine sample after completion of requested analyses and the demographic details will be collected from them as per the proforma. Participant informed consent will be shown to laboratory in charge. After completion of required analysis of urine samples, left over urine sample will be collected. The collected Urine sample will be stored and analyzed for microplastics using validated method. |