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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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Recurrent Calcic Urolithiasis
Institute of Nephrology
Published on BioPortfolio: 2014-08-27T03:17:39-0400
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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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