A Double-Blind, Randomized, Placebo-Controlled Phase Ⅱ Clinical Trial Of Potassium Citrate Sustained-Release Tablets In Therapy Of Hypocitraturia

[OBJECTIVE] Through double-blind, randomized, placebo-controlled phase II clinical trial, the efficacy and safety profile of potassium citrate sustained-release tablets produced by Lizhu corporation were evaluated in elevating the level of urinary citrate and PH value.[ METHODS ] A total of 40 consecutive patients with hypocitraturia were included and randomized into control group(CG, n=20) and treatment group(TG, n=20). The patients of CG received placebos and the potassium citrate sustained-release tablet was given to TG All of the patients were treated for two weeks in a double-blind manner. The efficacy and safety profile were evaluated by analysis of blood and urine samples before, during and after the trial. The adverse effects were also observed.[RESULTS] A total of 40 patients were enrolled into the trial and 35 patients completed 2 weeks' treatment with a withdraw rate of 12.5%. No significant differences of two groups were found in age, height, weight,...