Impact of empagliflozin on nephrolithiasis among patients without diabetes compared to a placebo in reduction in the number and/or size of renal stones

Phase 3

Conditions: ephrolithiasis

Registration Number: SLCTR/2023/012

Lead Sponsor: Professorial Medical Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

• Both male and female
• Minimum age- 18 yrs
• Maximum age- 75 yrs.
• Having renal parenchymal and pelvicalyceal stones
• With kidney stone with the size of more than four millimeters on abdominal CT scan

Exclusion Criteria

* Size less than four millimetre stones in the kidney
* Having ureteric stones
* Having known allergy to study drug
* eGFR less than 30 m2,
* Pregnant women
* Lactating women
* Kidney transplant patients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of the kidney stones and its mean size will be measured (The total volume of stones) before and after four weeks of treatment with study drugs/placebo. <br><br>Repeat CT abdomen (low dose protocol) will be done in four weeks (28-30 days) to reassess the size of the stone. <br><br>The mean size difference of the kidney stones will be compared in two groups before and following the intervention.<br> [Before and after four weeks of starting treatment]<br>

Secondary Outcome Measures

Name	Time	Method
umber of episodes of pain measured by visual analogue scale (1-10). New onset of colicky pain may reflect passage of parenchymal and pelvicalyceal stone through the ureter, thereby it may reflect reduction in size of the stone. This will be measured in 7 days and 28 days when we meet the patient physically. [This will be measured in 7 days and 28 days when we meet the patient physically. ]<br>2. Reduction in the number of stones<br><br>This study will only recruit renal parenchymal and pelvicalyceal stones. [The number of stones will be measured at the start and end of four weeks (28-30 days)]<br>