Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a comparison to placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, placebo-controlled randomized trial enrolling 100 men aged 50–80 with BPH. Participants will be assigned to Oxiblume:CoQ10 or placebo and followed for changes in urinary symptoms and prostate-related measures. Key eligibility includes IPSS 8–30, prostate volume 30–80 g, and specific urinary flow criteria. The trial is coordinated by G. Gennimatas Hospital in Thessaloniki, with standardized laboratory testing and data management. Safety and efficacy will be assessed through predefined clinical endpoints and monitored by the study team.

Why it matters

Who can join: the full rules

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) ≥8 and ≤30
4. Prostate volume ≥30gram and ≤80gram
5. Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
6. Post void residual volume ≤150ml

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.

Where it's running

• G.Gennimatas General Hospital
  Thessaloniki, Greece Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.