| CTRI Number |
CTRI/2025/02/080164 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to undesrstand what causes kidney stones to come back in patients visiting a big hospital in udupi district, karnataka |
|
Scientific Title of Study
|
A study to assess the factors leading to the recurrence of renal stones among patients reporting to tertiary care hospital of Udupi district, Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jimly Hazarika |
| Designation |
PG student |
| Affiliation |
MAHE,MANIPAL |
| Address |
Speciality Medical-Surgical Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi district.
Udupi
KARNATAKA
576104
India |
| Phone |
06001800149 |
| Fax |
|
| Email |
jimlyh95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Christabel |
| Designation |
Assistant Professor |
| Affiliation |
MAHE,MANIPAL |
| Address |
Department Medical-Surgical Nursing, Manipal College of Nursing, Manipal academy of higher education, Manipal, Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
9739319382 |
| Fax |
|
| Email |
soumya.christabel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Christabel |
| Designation |
Assistant Professor |
| Affiliation |
MAHE,MANIPAL |
| Address |
Department of Medical-Surgical Nursing, Manipal College of Nursing, Manipal academy of higher education, Manipal, Udupi District.
KARNATAKA
576104
India |
| Phone |
9739319382 |
| Fax |
|
| Email |
soumya.christabel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, 576104, India. |
|
|
Primary Sponsor
|
| Name |
Department of Urology |
| Address |
Kasturba Hospital, Manipal, Udupi District, Karnataka, 576104, India. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Jimly Hazarika |
Kasturba Hospital Manipal |
Urology DEpartment kasturba Hospital, Manipal udupi district
Udupi
KARNATAKA |
6001800149
jimlyh95@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) The inpatients and outpatients attending urology OPD were admitted to the urology ward with a renal stone recurrence.
2) Those who were willing to participate in the study.
3) Able to read and write. |
|
| ExclusionCriteria |
| Details |
1) Those who were not willing to participate in the study.
2) Patients with chronic renal failure and chronic urinary system disorders.
3) Patients who are mentally challenged.
4) Patients with other severe commodities that may affect the study (severe cardiovascular disease, advanced diabetes)
5) Patients who cannot read or write and have no means of assistance to complete the questionnaire. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study the outcome measures are, to assess the factors that lead to recurrence of renal
stone among patient that are diagnosed with recurrence of renal stone. |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
13/02/2025 |
| 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="0"
Months="1"
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
|
This research aims to determine and understand the specific factors leading to the recurrence of
renal stones. By uncovering these underlying factors, the study aims to provide insights for targeted
preventive measures and more effective management of renal stone recurrence. The interest in
conducting this study stems from the increasing prevalence of recurrence of renal stones and their
significant impact on patients’ health. Understanding these factors is crucial for developing personalized
treatment approaches and reducing the recurrence rates, ultimately improving patient outcomes and
reducing healthcare costs associated with recurrent kidney stones. To identify the factors leading to the recurrence of renal stones among patients attending urology OPD
and urology inpatients. H1: There will be a significant relationship between the factors and the recurrence of renal stones. |