| CTRI Number |
CTRI/2020/11/029244 [Registered on: 19/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between silodosin and tamsulosin for medical expulsive therapy of lower ureteric stones |
|
Scientific Title of Study
|
Comparison between silodosin and tamsulosin for medical expulsive therapy of distal ureteric calculus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atif Abdullah C |
| Designation |
MCh urology resident |
| Affiliation |
Chengalpattu Medical college |
| Address |
Department of Urology, Chengalpattu medical college, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8489972828 |
| Fax |
|
| Email |
atif2kin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh G |
| Designation |
Assistant Professor Urology |
| Affiliation |
Chengalpattu Medical college |
| Address |
Department of Urology,Chengalpattu Medical college, Chengalpattu, Tamil nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8489972828 |
| Fax |
|
| Email |
dr.gramesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atif Abdullah C |
| Designation |
MCh urology resident |
| Affiliation |
Chengalpattu Medical college |
| Address |
Department of Urology, Chengalpattu Medical College, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8489972828 |
| Fax |
|
| Email |
atif2kin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of urology, chengalpattu medical college |
|
|
Primary Sponsor
|
| Name |
Atif Abdullah C |
| Address |
26, 6th cross street, Anna nagar, chengalpattu Tamil nadu 603001 |
| Type of Sponsor |
Other [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 |
| Atif Abdullah C |
Department of Urology, Chengalpattu medical college |
VOC nagar, Chengalpattu
Kancheepuram
TAMIL NADU |
8489972828
atif2kin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical therapy |
One group of patients are given tablet silodosin 8mg HS OD for 2 weeks as medical expulsive therapy |
| Comparator Agent |
Medical therapy |
One group of patients are given tablet tamsulosin 0.4ug HS OD for 2 weeks as medical expulsive |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with lower ureteric stone less than 10mm are included |
|
| ExclusionCriteria |
| Details |
Bilateral renal or ureteric stone and patient with sepsis are excluded |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Passage of stone within 2 weeks |
Passage of stone within 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient not passing stone till 2weeks of therapy |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of this study is to evaluate the efficacy of alpha blockers for expulsion of distal ureteric calculus and to compare the efficacy of silodosin and tamsulosin |