- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04695951
Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Managua, Nicaragua, 13035
- Clinica Seniors Managua
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
kidney stone clearance with Renalof® treatment compared to placebo
Time Frame: 4 months
|
kidney stone clearance with Renalof® treatment compared to placebo measured by ultrasound and tomography imaging
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life of patients
Time Frame: 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,).
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4 months
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Number of colic
Time Frame: 4 months
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number of colic during the 4-month follow-up of treatment
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4 months
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Adverse events related with product of the trial
Time Frame: 4 months
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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,).
|
4 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of treatment
Time Frame: 4 months
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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
|
4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Johnson CM, Wilson DM, O'Fallon WM, Malek RS, Kurland LT. Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int. 1979 Nov;16(5):624-31. doi: 10.1038/ki.1979.173.
- Tsujihata M. Mechanism of calcium oxalate renal stone formation and renal tubular cell injury. Int J Urol. 2008 Feb;15(2):115-20. doi: 10.1111/j.1442-2042.2007.01953.x.
- Soucie JM, Coates RJ, McClellan W, Austin H, Thun M. Relation between geographic variability in kidney stones prevalence and risk factors for stones. Am J Epidemiol. 1996 Mar 1;143(5):487-95. doi: 10.1093/oxfordjournals.aje.a008769.
- Wesson JA, Johnson RJ, Mazzali M, Beshensky AM, Stietz S, Giachelli C, Liaw L, Alpers CE, Couser WG, Kleinman JG, Hughes J. Osteopontin is a critical inhibitor of calcium oxalate crystal formation and retention in renal tubules. J Am Soc Nephrol. 2003 Jan;14(1):139-47. doi: 10.1097/01.asn.0000040593.93815.9d.
- Kohri K, Yasui T, Okada A, Hirose M, Hamamoto S, Fujii Y, Niimi K, Taguchi K. Biomolecular mechanism of urinary stone formation involving osteopontin. Urol Res. 2012 Dec;40(6):623-37. doi: 10.1007/s00240-012-0514-y. Epub 2012 Nov 6.
- Mykoniatis I, Sarafidis P, Memmos D, Anastasiadis A, Dimitriadis G, Hatzichristou D. Are endourological procedures for nephrolithiasis treatment associated with renal injury? A review of potential mechanisms and novel diagnostic indexes. Clin Kidney J. 2020 May 22;13(4):531-541. doi: 10.1093/ckj/sfaa020. eCollection 2020 Aug.
- Grases F, Ramis M, Costa-Bauza A, March JG. Effect of Herniaria hirsuta and Agropyron repens on calcium oxalate urolithiasis risk in rats. J Ethnopharmacol. 1995 Mar;45(3):211-4. doi: 10.1016/0378-8741(94)01218-o.
- Beydokthi SS, Sendker J, Brandt S, Hensel A. Traditionally used medicinal plants against uncomplicated urinary tract infections: Hexadecyl coumaric acid ester from the rhizomes of Agropyron repens (L.) P. Beauv. with antiadhesive activity against uropathogenic E. coli. Fitoterapia. 2017 Mar;117:22-27. doi: 10.1016/j.fitote.2016.12.010. Epub 2016 Dec 29.
- Paslawska S, Piekos R. Studies on the optimum conditions of extraction of silicon species from plants with water. IV. Agropyron repens. Planta Med. 1976 Nov;30(3):216-22. doi: 10.1055/s-0028-1097720. No abstract available.
- Bragadottir G, Redfors B, Ricksten SE. Mannitol increases renal blood flow and maintains filtration fraction and oxygenation in postoperative acute kidney injury: a prospective interventional study. Crit Care. 2012 Aug 17;16(4):R159. doi: 10.1186/cc11480.
- Hagerstrom E, Lindberg L, Bentzen J, Brodbaek K, Zerahn B, Kristensen B. The Nephroprotective Effect of Mannitol in Head and Neck Cancer Patients Receiving Cisplatin Therapy. Clin Med Insights Oncol. 2019 Jan 7;13:1179554918821320. doi: 10.1177/1179554918821320. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201920-RENALOF-NI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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