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NCT05525130: FAGOTRICIA

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

Completed NA Last updated 23 February 2023
What this trial tests

NA trial testing Food supplement in Lithiasis in 81 participants. Completed in 5 October 2022.

Timeline
22 April 2020
Primary endpoint
16 September 2022
5 October 2022

Quick facts

Lead sponsorArafarma Group, S.A.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment81
Start date22 April 2020
Primary completion16 September 2022
Estimated completion5 October 2022
Sites3 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Arafarma Group, S.A. — full company profile →

Who can join

18 and older, any sex, with Lithiasis or Nephrolithiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomized, double-blind, placebo-controlled clinical trial of the use of hydroxycitric acid adjuvant to shock wave lithotripsy therapy in patients with calcium stones. Stone fragmentation results.
    Del Carmen Cano García M, Cobos RC, Bohorquez ÁV, Díaz PM, et al · · 2023 · cited 1× · PMID 37249658 · DOI 10.1007/s00240-023-01456-0

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05525130.

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