Clinical trial NCT04695951: Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
Official title: Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Injury
Kidney Injury
Kidney Calculi
Ureteral Obstruction
Ureteral Calculi
Renal Stone
Ureteral Injury
Renal Disease
Urolithiasis, Calcium Oxalate
Urolithiasis; Lower Urinary Tract
Urolithiasis
Keywords: Urolithiasis
Kidney Stone
Agropyron Repens
Ureteral calculi
Calcium oxalate
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: kidney stone clearance with Renalof® treatment compared to placebo
timeFrame: 4 months
Secondary outcomes:
measure: Quality of life of patients
timeFrame: 4 months
measure: Number of colic
timeFrame: 4 months
measure: Adverse events related with product of the trial
timeFrame: 4 months
Other outcomes:
measure: Cost of treatment
timeFrame: 4 months
Locations:
city: Managua
country: Nicaragua
facility: Clinica Seniors Managua
Study officials:
References:
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