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

NCT04860492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-09-26

No results posted yet for this study

Summary

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.

Conditions

  • Calculus of Upper Urinary Tract (Disorder)

Interventions

DIETARY_SUPPLEMENT

Renalof 325mg

RENALOF® is a preparation that contains active Agropyron repens extract. It is designed with specific antioxidant compounds triggered by a bio-catalyst process that enables improved control of the production mechanism of anti-stress molecules. RENALOF® contains extracts of couch grass (triticin, potassium salts, agropyron, silicic salt, inositol, vanillin, saponin, mucilage, iron, and others trace elements), mannitol, corn starch and magnesium silicate. The magnesium in RENALOF® inhibits stone formation by inhibition of growth of crystals and aggregation.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Petros Sountoulides, M.D, Phd · Aristotle Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-10-01
Completion
2022-12-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860492 on ClinicalTrials.gov