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Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.

NCT05525130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-02-23

No results posted yet for this study

Summary

The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself.

It is thought that additional treatments to the ESWL could improve the success rate of ESWL for less favorable stones.

The components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. Also these components show an inhibitory effect on the growth of calcium phosphate crystals. To sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones.

This is the reason why this experimental study aims to modify the size limit of the stones in the ESWL with adjuvant food supplement.

Conditions

  • Lithiasis
  • Nephrolithiasis

Interventions

DIETARY_SUPPLEMENT

Food supplement

FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.

DIETARY_SUPPLEMENT

Placebo

Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

Sponsors & Collaborators

  • Arafarma Group, S.A.

    lead INDUSTRY

Principal Investigators

  • Miguel Arrabal Martín, Dr · Hospital Universitario Clínico San Cecilio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2022-09-16
Completion
2022-10-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525130 on ClinicalTrials.gov