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

Sponsor

Catalysis SL (Industry)

Overall Status

Completed

CT.gov ID

NCT04695951

Collaborator

(none)

155

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Injury Kidney Injury Kidney Calculi Ureteral Obstruction Ureteral Calculi Renal Stone Ureteral Injury Renal Disease Urolithiasis, Calcium Oxalate Urolithiasis; Lower Urinary Tract Urolithiasis	Dietary Supplement: Renalof Other: Placebo	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Placebo Comparator: Control 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Renalof

Placebo Comparator: Control

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.

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.

Outcome Measures

Primary Outcome Measures

kidney stone clearance with Renalof® treatment compared to placebo [4 months]
kidney stone clearance with Renalof® treatment compared to placebo measured by ultrasound and tomography imaging

Secondary Outcome Measures

Quality of life of patients [4 months]
Quality of life was established in relation to the presence or absence of symptoms related to the disease by means of a bimonthly personal questionnaire: dysuria or burning when urinating, urinary urgency, kidney colic, difficulty in performing daily activities and periodicity of urinary infections (mild, moderate, severe, yes or no,).
Number of colic [4 months]
number of colic during the 4-month follow-up of treatment
Adverse events related with product of the trial [4 months]
Adverse effects related with the test product in patients with kidney stones, measured by means of a bimonthly personal questionnaire: nausea, vomiting, digestive pain, stomach ache... (mild, moderate, severe, yes or no,).

Other Outcome Measures

Cost of treatment [4 months]
cost of treatment with the use of Renalof® compared to the usual treatments, taking into account hospitalization time due to the number of colic and recovery time due to urolithiasis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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