| CTRI Number |
CTRI/2025/11/097714 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting Stone Passage: Blood and Imaging Markers in Ureteric Stone Treatment |
|
Scientific Title of Study
|
Role of hematological and radiological parameters in successful medical expulsion therapy for patients with ureteric calculus - An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balaji Subramaniam |
| Designation |
Senior Resident |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603203
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
drbalaji145@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. T Senthil Kumar |
| Designation |
Professor & HOD |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603203
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
hod.urolog.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Balaji Subramaniam |
| Designation |
Senior Resident |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603203
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
drbalaji145@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL |
| SRM Medical College Hospital and Research Centre, Kattankulathur, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital Research Institute |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 Balaji |
SRM Medical College Hospital Research Centre |
Department of Urology, 5th floor, SRM Medical College Hospital Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU |
044 4743 2350
drbalaji145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a radiological diagnosis of a single ureteral stoneless than or equal to 10mm on non-contrast-enhanced computerized tomography (NCCT).
Patients willing to receive medical expulsive therapy (tamsulosin 0.4 mg daily) and attend follow-up visits.
Age more than 8 year
|
|
| ExclusionCriteria |
| Details |
Multiple ureteral stones or concurrent renal stones.
Solitary kidney.
Associated chronic inflammatory conditions (e.g., autoimmune diseases).
Positive urine culture or high fever on presentation.
Renal impairment (serum creatinine significantly elevated).
Patients lost to follow-up.
Abnormal renal anatomy (such as ileal conduit/ horseshoe kidney)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the other radiological factors (Eg. Stone size, location, hydronephrosis) between both the groups. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the other radiological factors (Eg. Stone size, location, hydronephrosis) between both the groups. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "198"
Final Enrollment numbers achieved (India)="198" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
27/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/04/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
All Patients presenting with acute ureteric colic underwent NCCT to confirm a single ureteral stone less than or equal to 10 mm. Eligible patients provided informed consent and were enrolled for MET with tamsulosin 0.4 mg daily for 4 weeks. |