Condition: Benign Prostate Enlargement · Benign Prostate Hypertrophy(BPH) · Benign Prostate Obstruction (BPO) · Sponsor: G.Gennimatas General Hospital
Objectives of the study The aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients Study center The study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications). Patients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. Laboratory tests of all patients will be performed at the same microbiology laboratory. Study population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study. Study design Double-blind placebo-controlled randomized clinical trial Zero hypothesis (H0) and alternative hypothesis (H1): (H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients. (H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients. Study endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation. Secondary endpoints: * Adverse events rate in all patients during study period. * The difference between the Group A and Group B in the change of the IP…
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| G.Gennimatas General Hospital | Thessaloniki, Greece | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07638865