| CTRI Number |
CTRI/2024/03/063952 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing use of Tablet Tamsulosin with a combination of Tamsulosin and Deflazacort for clearance of ureteric stones less than 8 mm. |
|
Scientific Title of Study
|
Tamsulosin alone and in combination with Deflazacort for medical expulsion therapy of distal ureteric calculus (less than 8mm): a randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautam Girish |
| Designation |
MCh student |
| Affiliation |
Kasturba medical college |
| Address |
Department of urology, Kasturba medical college, Manipal , Udupi
Udupi KARNATAKA 576104 India |
| Phone |
09497363198 |
| Fax |
|
| Email |
drgautam89@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sunil Pillai |
| Designation |
Head of deapartment |
| Affiliation |
Kasturba medical college |
| Address |
Department of urology, Kasturba medical college, Manipal , Udupi
Udupi KARNATAKA 576104 India |
| Phone |
9731855209 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Sunil Pillai |
| Designation |
Head of deapartment |
| Affiliation |
Kasturba medical college |
| Address |
Department of urology, Kasturba medical college, Manipal , Udupi
Udupi KARNATAKA 576104 India |
| Phone |
9731855209 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr Gautam Girish |
| Kasturba medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Gautam Girish |
| Address |
Department of urology, Kasturba medical college, manipal, udupi, Karnataka |
| 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 |
| Dr Gautam Girish |
kasturba medical college |
Room No 14, Department of urology, Kasturba medical college, Manipal , Udupi Udupi KARNATAKA |
09497363198
drgautam89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics 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 |
Tamsulosin |
Tamsulosin 0.4 mg PO once daily dose at night for 2 weeks alone for expulsion of distal ureteric calculus |
| Intervention |
Tamsulosin + Deflazacort |
Tamsulosin 0.4 mg PO with Deflazacort 30 mg PO both once daily dose at night for 2 weeks for expulsion of distal ureteric calculus 8 mm in size |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients who report to emergency/ Urology OPD with ureteric calculi 8 mm or less in size
2) Willing to consent for the study
|
|
| ExclusionCriteria |
| Details |
Patient with urinary tract infection based on urine routine analysis and fever
Uncontrolled pain
Impaired kidney function Serum creatinine more than 1.4 mg/dl
Solitary kidney
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess stone expulsion rates on treatment with alpha blockers (Tamsulosin) and in combination with corticosteroids (Tamsulosin and Deflazacort) in patients diagnosed with distal ureteric calculus (less than 8mm) |
Stone expulsion rate assessed at 2 weeks or when patient gives history of passage of stone whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess stone expulsion rates on treatment with alpha blockers Tamsulosin alone and in combination with corticosteroids Tamsulosin and Deflazacort in patients diagnosed with ureteric calculus less than 8mm at 2 weeks
To assess stone expulsion based on size of stone less than 5mm and between 5 to 8 mm
Quantification of Analgesics using analgesic quantification score
Average time of stone clearance on NCCT KUB on history of passage of stone or at 02 weeks whichever is earlier
|
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
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)
|
18/03/2024 |
| 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="5" Days="20" |
|
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
|
Medical expulsion therapy (MET) is a non-surgical therapeutic option that is used for expulsion of calculus in uncomplicated symptomatic ureteral calculus cases . A variety of medications including alpha blockers, calcium channel blockers, phosphodiesterase inhibitors and corticosteroids have been tried to increase the expulsion rates and provide symptomatic relief to patients during the course of treatment. [1-4] But uncertainty still persist on the natural history of stone passage versus MET. Data and recommendations regarding use of alpha blockers are available, but insufficient data is available on use of corticosteroids to make a strong recommendation for its use.[5] Based on mechanism of action selective Alpha blockers act on Alpha1a receptors thereby causing dilatation of ureter and increased passage of ureteric calculus. Corticosteroids acts by reducing ureteral oedema, often seen at the time of ureteroscopy, thereby increasing the stone passage. Overall lifetime prevalence of kidney stone disease varies from 1-15 % depending on race, sex, region and ethnicity with complications ranging from severe colicky pain to non-functional kidney requiring nephrectomy. Severity of pain affects the quality life of patients. Medical expulsion therapy helps in alleviating symptoms and avoiding active surgical intervention thereby reducing the cost, complications (surgical and anaesthesia related) and loss of work. MET also reduces the time of spontaneous stone passage and symptom. Through this study we aim to assess effect of alpha blockers alone and in combination with corticosteroid on stone expulsion rates in patients with distal ureteric calculus and to assess the effect of these medication on reduction in analgesics requirement. |