NCT04860492: AMMOS

The Impact of Renalof® Dietary Supplement on Upper Urinary Tract Stone Volume

Completed NA Last updated 26 September 2023

What this trial tests

NA trial testing Renalof 325mg in Calculus of Upper Urinary Tract (Disorder) in 82 participants. Completed in 1 December 2022.

Timeline

1 September 2020

Primary endpoint
1 October 2022

1 December 2022

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	82
Start date	1 September 2020
Primary completion	1 October 2022
Estimated completion	1 December 2022
Sites	1 location across Greece

Drugs / interventions tested

• Renalof 325mg

Conditions studied

• Calculus of Upper Urinary Tract (Disorder) — all drugs for Calculus of Upper Urinary Tract (Disorder) →

Sponsor

Aristotle University Of Thessaloniki

Who can join

18 and older, any sex, with Calculus of Upper Urinary Tract (Disorder). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. All patients will also have a free flow mid-stream urinalysis and culture before randomization.

The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study.

Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire (m-USSQ) and the PUF questionnaire completed one week into study, before commencement of treatment and at the end of the study after taking either RENALOF® or placebo. Patients with a DJ stent in situ at study entry, will have both ends of the DJ cut and send for culture during scheduled DJ stent change. Approximately 90 days after recruitment, all patients will have a follow up CT scan, done at "G. Gennimatas" hospital radiology department and evaluated by the same dedicated uroradiologist , and a mid-stream urinalysis and culture. Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis. All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires.

During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.