| CTRI Number |
CTRI/2019/07/019961 [Registered on: 01/07/2019] Trial Registered Prospectively |
| Last Modified On: |
27/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF TAMSULOSIN AND SILODOSIN IN TREATMENT OF LOWER URETERIC STONES |
|
Scientific Title of Study
|
COMPARISON OF EFFICIENCY OF TAMSULOSIN VS SILODOSIN IN THE TREATMENT OF LOWER URETERIC CALCULUS-RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunchand R |
| Designation |
Junior Resident Surgery |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Surgery
Armed Forces Medical College
Pune
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
8547861531 |
| Fax |
|
| Email |
r.arunchand.89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurakshat Gupta |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
DEPARTMENT OF SURGERY
ARMED FORCES MEDICAL COLLEGE
PUNE
Pune
MAHARASHTRA
411040
India |
| Phone |
9453507975 |
| Fax |
|
| Email |
anurakshat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arunchand R |
| Designation |
Resident Surgery |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Surgery
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8547861531 |
| Fax |
|
| Email |
r.arunchand.89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Pune, Maharashtra |
|
|
Primary Sponsor
|
| Name |
ARUNCHAND R |
| Address |
DEPARTMENT OF SURGERY
ARMED FORCES MEDICAL COLLEGE
PUNE |
| 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 |
| ARUNCHAND R |
ARMED FORCES MEDICAL COLLEGE |
Armed Forces Medical College
PUNE
MAHARASHTRA - 411040
Pune
MAHARASHTRA |
8547861531
r.arunchand.89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL RESEARCH CELL & INSTITUTIONAL ETHICAL COMMITTEE, ARMED FORCES MEDICAL COLLEGE |
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 |
SILODOSIN |
SILODOSIN 8mg HS orally till expulsion of calculus or a maximum period of 30 days |
| Comparator Agent |
TAMSULOSIN |
TAMSULOSIN 0.4mg HS orally till expulsion of calculus or maximum period of 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Unilateral distal ureteric calculus
b) Size < 10 mm
c) Normal renal parameters (Serum Urea & Serum Creatinine)
d) Age 18-60 yrs |
|
| ExclusionCriteria |
| Details |
a) Single kidney
b) Bilateral ureteric stone
c) Mid/upper ureteric calculus
d) Renal impairment
e) High grade hydroureteronephrosis (Grade III & IV as per Society of Fetal Ultrasound, SFU)
f) Any h/o previous endoscopic/ surgical/ ESWL interventions
g) Intolerable side-effects (Hypotension) to either tamsulosin/ silodosin
h) Evidence of UTI
j) Concomitant kidney/bladder stones
k) Patients already on any alpha blocker for BPH |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| STONE CLEARENCE RATE (%) |
1. Passing of stone
2. 04 weeks elapsed and surgical intervention planned
3. Symptoms of patient demanding interventional procedures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| STONE EXPULSION TIME (DAYS) |
1. Passing of stone
2. 04 weeks elapsed and surgical intervention planned
3. Symptoms of patient demanding interventional procedures |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
70% ureteric calculus are situated in lower 1/3rd of ureter, referred as Distal Ureteric Stones (DUS). Medical Expulsion Therapy(MET) has replaced minimally invasive procedures due to incidence of major complications including ureteric avulsions, perforation & strictures in the latter. Uroselective Alfa adrenergic blockers as MET has been accepted as first line management of small lower ureteric calculus as various meta analysis shows stone passage of 44% - 52%. However MET has been associated with side effects including retrograde ejaculation. Identification of α1A adrenoreceptor blocker capable of lesser side effects has been proposed as an alternative to α1 adreno receptor blocker. The objective of study is to compare efficiecy of Tamsulosin vs Silodosin as MET of DUS in terms of stone clearence rate and stone expulsion time. Randomisation will be achived by Block Randomisation and results are to be compared with appropriate statistical software. |