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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  
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 
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  
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  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.

 

 
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