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

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Renal Stone; Urolithiasis; Ureteral Calculi; Ureteral Injury; Ureteral Obstruction; Renal Disease; Kidney Injury; Urolithiasis, Calcium Oxalate; Urolithiasis; Lower Urinary Tract; Kidney Calculi; Renal Injury

Treatments: Dietary Supplement: Renalof; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04695951

201920-RENALOF-NI

Details and patient eligibility

About

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

Full description

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

The treatment group consists of 120 patients over 18 years of age, of both sexes, with a diagnosis of urolithiasis less than 10 mm in diameter, present throughout the entire reno-uretero-bladder path, diagnosed by ultrasound, renal CT and urography . The Renalof® product was administered at a dose of 650 mg daily for 3 months and the presence of stones in any location of the reno-ureteral tract was evaluated using one of the diagnostic means mentioned in monthly consultations. The second group, treated with placebo corresponding to 35 people constituting 30% of the universe. The study period was from August 2019 to July 2020 at the Hospital Escuela Antonio Lenin Fonseca and the Seniors clinic, in the city of Managua, Nicaragua.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient over 18 years of age, in all their mental and physical capacities to decide to be part of this study.
2. There are no comorbidities or associated diseases that put the stability of the patient at risk.
3. Not be diagnosed as Chronic Kidney Disease, in any stage.
4. Existence of non-obstructive stones smaller than 10 mm located in the renoureteral path.
5. No compromise of renal viability.

Exclusion criteria

1. Patients under 18 years of age.
2. Existence of comorbidities or associated diseases that put the stability of the patient at risk.
3. Existence of a diagnosis of Chronic Kidney Disease, at any stage.
4. Presence of non-obstructive or obstructive stones greater than 10 mm located in the renoureteral path.
5. Renal viability compromise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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155 participants in 2 patient groups, including a placebo group

Renalof

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Renalof

Control

Placebo Comparator group

Description:

A total of 35 patients treated with the study product 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.

Treatment:

Other: Placebo