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The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Renalof |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renalof | Dietary Supplement | One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment) | 12 weeks | |
| Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment | 12 weeks | |
| Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Calciuria at week 12 | 12 weeks | |
| Uricosuria at week 12 | 12 weeks | |
| Blood Uric acid at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirna Atiés Sánchez, MD | Institute of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nephrology | Havana | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Dietary Supplement | One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks |
|
| 12 weeks |
| Oxaluria at week 12 | 12 weeks |
| Citraturia at week 12 | 12 weeks |
| Phosphatemia at week 12 | 12 weeks |
| Calcemia at week 12 | 12 weeks |
| Total plasmatic calcium at week 12 | 12 weeks |
| Blood ionic calcium at week 12 | 12 weeks |
| Calcium Oxalate crystallization risk at week 12 | 12 weeks |
| Calcium phosphate activity product at week 12 | 12 weeks |
| Calcium Oxalate activity product at week 12 | 12 weeks |
| pH of urine at week 12 | 12 weeks |
| Presence of adverse effects at any moment of treatment | 12 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |