L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeni-Suef University
About this trial
This study will compare L-citrulline and tamsulosin as medical expulsive therapy for adults with single distal ureteral stones.
Eligible participants with a single distal ureteral stone measuring 5 to 10 mm will be randomly assigned to receive either oral L-citrulline 750 mg twice daily or oral tamsulosin 0.4 mg once daily. Treatment will continue until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
Participants will be followed weekly for up to 4 weeks. The main outcome is stone expulsion within 4 weeks. The study will also assess time to stone expulsion, pain episodes, analgesic use, need for additional intervention, and adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 60 years.
Single distal ureteral stone.
Stone size 5 to 10 mm.
Normal renal function.
Disqualifiers
Fever or active urinary tract infection.
Severe hydronephrosis.
Solitary kidney.
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
L-Citrulline
DrugOral L-citrulline 750 mg twice daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
Tamsulosin
DrugOral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: L-Citrulline Plus Tamsulosin PlaceboExperimental treatment 1 intervention
Group B: Tamsulosin Plus L-Citrulline PlaceboActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stone Expulsion Rate Within 4 Weeks
Stone expulsion rate will be defined as the proportion of randomized participants with confirmed stone passage within 4 weeks. Stone expulsion will be confirmed by patient-reported stone passage with stone capture, or by absence of the ureteral stone on follow-up imaging.
Time frame
Within 4 weeks after randomizationSecondary outcomes
1
Time to Stone Expulsion
Time to stone expulsion will be defined as the number of days from randomization to confirmed stone passage. Stone passage will be confirmed by patient-reported stone passage with stone capture, or by absence of the ureteral stone on follow-up imaging.
Time frame
From randomization up to 4 weeks2
Number of Pain Episodes
The number of renal colic pain episodes reported by each participant during the follow-up period will be recorded and compared between the study groups.
Time frame
From randomization up to 4 weeks3
Analgesic Use
Analgesic use will be assessed by recording the number of analgesic doses required by each participant during the follow-up period.
Time frame
From randomization up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov