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2012, Number 1

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Rev Cubana Invest Bioméd 2012; 31 (1)

Randomized double-blind study with Renalof in patients with calcium oxalate renal lithiasis

Atiés SMC, Edighill VV, Abreu VR

Language: Spanish
References: 34
Page: 87-100
PDF size: 236.40 Kb.


ABSTRACT

A double-blind, randomized, placebo-controlled, parallel group phase III clinical trial was conducted with the purpose of evaluating the effectiveness and safety of Renalof to remove and/or reduce calcium lithiasis in patients with calcium urolithiasis. The patients chosen were aged 18-65 and had stones smaller than 10 mm. These patients were treated with a natural product manufactured by the Spanish laboratory Catálisis SA, in a dosage of 1 capsule 3 times a day during 3 months, and monthly clinical, radiological, tomographic and echographic follow-up to record adverse effects. The main evaluation criterion was the size and number of the calculi, with favorable response when they either disappeared or their size was reduced. 110 patients were randomized to Renalof (n=52) and placebo (n=58). Stone size reduction was 7.7 % for the Renalof group and 0 % for the placebo group by the third month, whereas the stone disappearance response was 86.5 % by the third month for the Renalof group. The mean number of colics decreased by the third month, with only 0.4 ± 1.3 for the Renalof group. It was concluded that Renalof is an efficient product for the destruction or reduction of calcium renoureteral calculi, with no adverse effects.


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