An interventional study of Food supplement and Placebo in Lithiasis and Nephrolithiasis, sponsored by Arafarma Group, S.A.. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by Arafarma Group, S.A. · Not applicable, Interventional, and Treatment
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.
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.
11 studies on the registry are indexed under Lithiasis; 2 are open to participants now.
Browse Lithiasis studies →Arafarma Group, S.A. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Dietary Supplement: Food supplement
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Dietary Supplement: Placebo
FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.
Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the % of reduction of the size (area) of lithiasis through imaging tests.
Time frame: 10 weeks after baseline visit
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the number of generated fragments through imaging tests.
Time frame: 10 weeks after baseline visit
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the hardness of lithiasis through imaging tests.
Time frame: 10 weeks after baseline visit
Rate of morbidities related to the ESWL between both treatment groups.
All episodes of morbidities related to the ESWL will be recorded, whether considered relevant.
Time frame: 2 weeks and 6 weeks after ESWL
Plan to share: Undecided
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Arafarma Group, S.A.