CompletedNot Applicable

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

Spain81 participantsStarted 2020-04-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by ESWL, being symptomatic with little probability of spontaneous expulsion. * Signed informed consent to participate in the clinical study. Exclusion Criteria: * Lithiasis of more than 20 mm and less than 15 mm for the largest diameter. * Taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin B6, vitamin D, vitamin A, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals). * Taking medications that influence urine pH (citrate, bicarbonate, carbonic anhydrase inhibitors, L-methionine, vitamin C, ammonium chloride). * Taking selective serotonin reuptake inhibitor antidepressant medications. * Taking anticoagulants and antiaggregants. * ESWL contraindications: urine infection, active or recurrent; hemorrhagic diathesis; pregnant or lactating patients; others (extreme obesity, arterial aneurysm near the location of the stone, etc.).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.

Timeframe: 10 weeks after baseline visit

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.

Timeframe: 10 weeks after baseline visit

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.

Timeframe: 10 weeks after baseline visit

Trial details

NCT IDNCT05525130

SponsorArafarma Group, S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-16

View on ClinicalTrials.gov More Lithiasis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.

Timeframe: 10 weeks after baseline visit

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.

Timeframe: 10 weeks after baseline visit

Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.

Timeframe: 10 weeks after baseline visit