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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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.

 
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