| CTRI Number |
CTRI/2021/08/035595 [Registered on: 11/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between tamsulosin and silodosin in terms of benefits and safety in patients with lower ureteric calculus of size less than or equal to size 10 mm. |
|
Scientific Title of Study
|
Comparative Study On Efficacy And Safety Of Tamsulosin Vs Silodosin In Patients With Distal Ureteric Calculus Of Size ≤ 10 mm |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar Prabhat |
| Designation |
Mch Urology Resident |
| Affiliation |
Dr PSIMS and RF |
| Address |
Dr Pinnamaneni siddhartha institute of medical sciences and research foundation campus, chinnaoutpalli, gannavaram, krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9075631360 |
| Fax |
|
| Email |
pmttarget@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayapule Sreedhar |
| Designation |
Professor , MS, MCh Urology |
| Affiliation |
Dr PSIMS and RF, Dr NTR university Vijayawada |
| Address |
Dr Pinnamaneni siddhartha institute of medical sciences and research foundation campus, chinnaoutpalli, gannavaram, krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9901398866 |
| Fax |
|
| Email |
sreedh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar Prabhat |
| Designation |
Mch Urology Resident |
| Affiliation |
Dr PSIMS and RF |
| Address |
Dr Pinnamaneni siddhartha institute of medical sciences and research foundation campus, chinnaoutpalli, gannavaram, krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9075631360 |
| Fax |
|
| Email |
pmttarget@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Arvind Kumar Prabhat |
| Address |
Dr Pinnamaneni siddhartha institute of medical sciences and research foundation campus, chinnaoutpalli, gannavaram, krishna district |
| 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 |
| Arvind Kumar Prabhat |
Dr Pinnamaneni Siddhartha institute of medical sciences and research foundation |
Department of Urology
New building
Room number- 01
Krishna
ANDHRA PRADESH |
9075631360
pmttarget@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. PSIMS AND RF |
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 |
One arm - Tamsulosin
other arm - Silodosin |
Tamsulosin-
Dose -0.4 mg
Frequency- 1 tablet in the night
Route- Oral
Duration- 7 days
Silodosin -
Dose- 8 mg
Frequency- 1 tablet in the night
Route - Oral
Duration- 7 days |
| Comparator Agent |
Tamsulosin Vs Sildosin |
Comparative study on efficacy and safety of tamsulosin Vs Sildosin in patients with distal ureteric calculus of size less than or equal to 10 mm |
| Intervention |
Tamsulosin Vs Silodosin |
Group 1- Tamsulosin
and Group 2- Silodosin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) All adult subjects coming to Urology OPD with ureteric colic.
2) Unilateral single distal ureteric calculus of size ≤ 10 mm diagnosed on CTKUB plain.
3) Subjects with prior informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Subjects who do not want to undergo medical expulsion therapy (MET) and want immediate surgical management.
2) Breastfed and Pregnant women.
3) Subjects with congenital anomalies of genitourinary and gastrointestinal tract.
3) Subjects with fever.
4) Subjects with impaired renal function.
5) Subjects in ICU with urinary sepsis.
6) Lower ureteric calculi size > 10 mm.
7) Multiple distal ureteric calculus.
8) Bilateral lower ureteric calculus.
9) Calculus in single functioning kidney (SFK).
10) Subjects on hemodialysis.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Which drug ( Tamsulosin or Silodosin) has more efficacy and safety in patients with distal ureteric calculus of size less than or equal to 10 mm |
Effect of Medical expulsion therapy ( Tamsulosin or Silodosin ) in terms of expulsion of calculus in patients with distal ureteric calculus of size equal to or less than 10 mm over a duration of 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know efficacy and safety of tamsulosin and silodosin as a medical expulsion therapy in patients with distal ureteric calculus of size equal to or less than 10 mm. |
Total duration of study - 1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
To compare the efficacy and safety of tamsulosin and silodosin among the subjects with distal ureteric calculus of size less than or equal to 10 mm - 1) Medical expulsion therapy in distal ureteic calculus. 2) Time taken for expulsion of the calculus. 3) Analgesic requirement. 4) Rate of failure of spontaneous distal ureteric calculus expulsion on medical expulsion therapy and need of surgical intervention. |