| CTRI Number |
CTRI/2025/03/082491 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare the efficacy of tablet Silodosin vs tablet Tadalafil for lower ureteric calculi expulsion |
|
Scientific Title of Study
|
Effectiveness of Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi - A Randomised Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJeyapal Parthiban |
| Designation |
Post Graduate in General Surgery |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
C Block Department of General Surgery
Aarupadai Veedu Medical College , Kirumampakkam , Pondicherry
PONDICHERRY 607402 India |
| Phone |
9585997497 |
| Fax |
|
| Email |
parthiban.jayapal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKRavichandran |
| Designation |
Professor and HOD |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
C Block Department of General Surgery
Aarupadai Veedu Medical College , Kirumampakkam , Pondicherry
PONDICHERRY 607402 India |
| Phone |
9443091259 |
| Fax |
|
| Email |
drkravichandranyadav@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrKRavichandran |
| Designation |
Professor and HOD |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
C Block Department of General Surgery
Aarupadai Veedu Medical College , Kirumampakkam , Pondicherry
PONDICHERRY 607402 India |
| Phone |
9443091259 |
| Fax |
|
| Email |
drkravichandranyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadi Veedu Medical and Hospital , Kirumampakkam , Pondicherry 607402 , India |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
C Block Department of General Surgery
Aarupadai Veedu Medical College , Kirumampakkam , Pondicherry |
| 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 |
| DrJeyapal Parthiban |
Aarupadai Veedu Medical College |
Room No 10 ,C Block , Department of General Surgery , Aarupadai Veedu Medical College and Hospital , Kirumampakkam , Pondicherry Pondicherry PONDICHERRY |
9585997497
parthiban.jayapal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL 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 |
| Comparator Agent |
Tablet Silodosin |
Tablet Silodosin is given Per Oral at 8 mg once daily after food for 4 weeks |
| Intervention |
Tablet Tadalafil |
Tablet Tadalafil is given Per Oral at 5mg once daily after food for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient from 18 years to 60 years
Both Genders
Patients with ureteric calculi of size 5 to 10 mm in greatest dimension confirmed by CT-KUB and X-Ray KUB . |
|
| ExclusionCriteria |
| Details |
Patients not willing for study
Patients with functional / anatomical abnormalities in ureter
Patients with multiple ureteric stone
Patients with Bilateral Ureteric stones
Pregnant and Lactating mothers
Patients with vertigo , cardiac abnormalities, hypotension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi |
Expulsion of ureteric calculi at 0,2and 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out difference in duration of time in Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi |
Expulsion of ureteric calculi at 0,2 & 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
29/03/2025 |
| 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="6" 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
|
After correction from the IRC&IEC, convenient sampling of patients attending opd services during the study period mentioned, fulfilling the inclusion and exclusion criteria as listed will be recruited for the study, after obtaining informed written consent under the guidance of the guide and co-guide. The nature, purpose and their roles in the study will be explained in detail, including the information that their non-participation in the study would not affect the quality of their treatment that they are to receive and that they are free to exit the study at any time. After assuring that their responses would remain confidential, an informed written consent for the same shall be obtained from all participants Data will be collected using a pre-tested semi-structured proforma to collect sociodemographic details about the patients participating in the study. Patients based on convenience sampling will be divided into group A & group B . Both the groups detailed history will be taken and routine investigation like Hb,TC,DC,ECG, RFT, Urine Routine , Urine Culture, X-Ray KUB, USG KUB and CT-KUB will be taken . Participants were then randomly assigned into two groups, Group A and Group B. Patients in Group A received Silodosin 8 mg once daily, while those in Group B received Tadalafil 5 mg once daily. The assigned medication was continued until stone expulsion or for a maximum duration of four weeks. Throughout the study, all patients underwent regular assessments, including physical examinations, blood urea and serum creatinine levels, urine culture, and repeat radiological investigations as needed. In addition to the allocated treatment, patients were advised to increase fluid intake and were prescribed Diclofenac 50 mg orally during pain episodes.Patients were followed up for a period of four weeks, during which the primary and secondary endpoints were evaluated. The primary endpoint was the stone expulsion rate, while secondary endpoints included stone expulsion time, defined as the number of days from randomization to the confirmed expulsion of the stone, intervention rates such as the need for ureteroscopy in cases where spontaneous expulsion did not occur, the number of pain episodes experienced by the patient, and adverse effects associated with MET. Stone expulsion was confirmed through CT-KUB and X-ray KUB. |