Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

July 1, 2020

Study Completion Date

October 1, 2020

Conditions
Renal InjuryKidney InjuryKidney CalculiUreteral ObstructionUreteral CalculiRenal StoneUreteral InjuryRenal DiseaseUrolithiasis, Calcium OxalateUrolithiasis; Lower Urinary TractUrolithiasis
Interventions
DIETARY_SUPPLEMENT

Renalof

A total of 120 patients treated with the study product Renalof® at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.

OTHER

Placebo

A total of 35 patients treated with Placebo at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.

Trial Locations (1)

13035

Clinica Seniors Managua, Managua

All Listed Sponsors
lead

Catalysis SL

INDUSTRY

NCT04695951 - Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract | Biotech Hunter | Biotech Hunter