NCT05525130

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

Experimental Study of the Administration of a Food Supplement Containing Hydroxycitric Acid Versus Placebo in Patients With Oxalate and Calcium Phosphate Lithiasis in Whom Extracorporeal Shock Wave Lithotripsy is Indicated.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Arafarma Group, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study treatment will be administered for 10 weeks. First, one dose will be administered every 12 hours for each patient during the 4 weeks prior to ESWL. After ESWL, and for 6 weeks, one dose will be administered every 24 hours.

Conditions

• Lithiasis
• Nephrolithiasis

Interventions

Type	Name	Description
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®.

Timeline

• Start date: 2020-04-22
• Primary completion: 2022-09-16
• Completion: 2022-10-05
• First posted: 2022-09-01
• Last updated: 2023-02-23

Locations

3 sites across 1 country: Spain