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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food supplement | Experimental | Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. |
|
| Placebo | Placebo Comparator | Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food supplement | Dietary Supplement | FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 10 weeks after baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks and 6 weeks after ESWL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Arrabal Martín, Dr | Hospital Universitario Clínico San Cecilio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Clínico San Cecilio | Granada | 18016 | Spain | |||
| Hospital Universitario Regional de Málaga |
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| ID | Term |
|---|---|
| D020347 | Lithiasis |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Dietary Supplement | Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®. |
|
| Málaga |
| 29010 |
| Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |