| CTRI Number |
CTRI/2026/01/100858 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study between Tamsulosin and in Combination with Deflazacort in Distal Ureteric Calculus less than 10mm |
|
Scientific Title of Study
|
Tamsulosin alone and in Combination with Deflazacort for Medical Expulsion therapy of Distal Ureteric Calculus less than 10mm: A Randomized Controlled Study |
| Trial Acronym |
MET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Pusarla Subash Chandra |
| Designation |
Senior Resident |
| Affiliation |
MBBS, M.S(General surgery) |
| Address |
Room no 14, OPD Building, Department of Urology and Renal Transplant, KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8978252790 |
| Fax |
|
| Email |
psubashchandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sunil Pillai Bhaskarsa |
| Designation |
Professor & HOD |
| Affiliation |
MBBS, MS(Gen Surgery), MRCS(Glasgow), Mch(Urology), FRCS(Urology)(Glasgow) |
| Address |
Room no 14, OPD Building, Department of Urology and Renal Transplant, KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9731855209 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pusarla Subash Chandra |
| Designation |
Senior Resident |
| Affiliation |
MBBS, M.S(General surgery) |
| Address |
Room no 14, OPD Building, Department of Urology and Renal Transplant, KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8978252790 |
| Fax |
|
| Email |
psubashchandra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pusarla Subash Chandra |
| Address |
Room No 14 OPD Building Department of Urology and Renal Transplant KMC MANIPAL karnataka India 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Pusarla Subash Chandra |
KMC MANIPAL |
Room no 14, OPD Building, Department of Urology and Renal Transplant, Kasturba medical college, MANIPAL. Udupi(Dt). Karnataka. India
Udupi
KARNATAKA |
8978252790
psubashchandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
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 |
| Comparator Agent |
Tamsulosin |
0.4mg per oral for 3 weeks |
| Intervention |
Tamsulosin + Deflazacort |
0.4mg + 30mg per oral for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients who report to emergency/ Urology OPD with ureteric calculi 10 mm or less in
size willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
1) Patient with urinary tract infection (based on urine routine analysis and fever),2) Uncontrolled pain,3) Impaired kidney function (Serum creatinine greater than 1.4 mg/dl), 4) Solitary kidney,5) Diabetic patients(HbA1c greater than 7%) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess stone expulsion rates on treatment with alpha blockers (Tamsulosin) and in combination
with corticosteroids (Tamsulosin + Deflazacort) in patients diagnosed with distal ureteric calculus less than or equal to 10mm |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess stone expulsion based on size of stone (less than 5mm, 5-10 mm) |
3 weeks |
| Quantification of Analgesics used (using analgesic quantification score) |
3 weeks |
Average time of stone clearance (NCCT KUB on h/o passage of stone or at 03 weeks whichever is
earlier). |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/01/2026 |
| 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="2"
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
|
This study is a randomized controlled study comparing Tamsulosin alone and in combination with Deflazacort for medical expulsion therapy of Distal Ureteric Calculus less than or equal to 10mm for 2 years that will be conducted at Kasturba Hospital Manipal. The primary outcome will be to assess stone expulsion rate at 3 weeks. The secondary outcomes will be stone expulsion rate based on size, quantification of analgesics used and average time of stone clearance. |