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โ† Trials
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Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:

RecruitingNAAges 50 Years - 80 YearsMaleG.Gennimatas General Hospital
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In plain words

What the trial is, and whether it could suit you

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 c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participant must be between 50 and 80 years old. 2. Participant has signed and dated the appropriate Informed Consent document. 3. International Prostate Symptom Score (IPSS) โ‰ฅ8 and โ‰ค30 4. Prostate volume โ‰ฅ30gram and โ‰ค80gram 5. Peak urinary flow rate (Qmax) โ‰ฅ5 ml/sec and โ‰ค15ml/sec 6. Post void residual volume โ‰ค150ml Exclusion Criteria: 1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention. 2. Participant has a history of prostate, bladder or urethral cancer. 3. Participant has undergone pelvic radiation or systemic chemotherapy. 4. Participant has undergone intravesical chemotherapy. 5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder. 6. Participant has undergone prostate surgery 7. Participant with penile or urinary sphincter implants. 8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder). 9. Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results. 10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis. 11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
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What it tests

  • Oxiblume:CoQ10 (Ralivia) therapy
  • Placebo Pill.
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Where

1 site
G.Gennimatas General Hospital
Thessaloniki, Greece
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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