Actively Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) A Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety
Led by G.Gennimatas General Hospital · Updated on 2026-06-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy for men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). This condition involves discomfort or pain in the pelvic or perineal area lasting at least three months within the last six months. The trial is a double-blind, placebo-controlled, randomized clinical study coordinated by the 1st Urology Department at Aristotle University of Thessaloniki, Greece. Participants will be randomly assigned to one of two groups: the active treatment group receiving one pill of Ralivia daily for three months, or the placebo group receiving a daily placebo pill for the same period. The study includes two follow-up visits at 6 and 12 weeks after starting treatment, during which clinical symptoms and various health parameters will be assessed. During the study, participants will complete questionnaires assessing pain, urinary symptoms, erectile function, and quality of life. Blood tests measuring inflammatory markers and prostate-specific antigen will be performed, and adverse events will be monitored throughout. The primary outcome is the change in the pain score from baseline to 12 weeks. Total participation lasts at least 12 weeks with close monitoring of symptoms and safety.
CONDITIONS
Brief Title
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged between 18 and 50 years
- Signed and dated informed consent document
- Clinical diagnosis of CP/CPPS with pelvic or perineal pain lasting at least 3 months within the last 6 months
You will not qualify if you...
- Evidence of facultative Gram negative or enterococcus bacteria ≥ 1000 CFU/ml in mid-stream urine
- History of prostate, bladder, or urethral cancer
- Previous pelvic radiation or systemic chemotherapy
- Previous intravesical chemotherapy
- Unilateral orchialgia without pelvic symptoms, active urethral stricture, bladder stones, or other urological conditions linked to lower urinary tract symptoms
- Any neurological disease or disorder affecting the bladder
- Previous prostate surgery or treatment
- Presence of penile or urinary sphincter implants
- Cancer diagnosis within the last 5 years or any pelvic surgery
- Neurological impairment or psychiatric disorder preventing consent understanding or protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either Oxiblume:CoQ10 (Ralivia) therapy or a placebo pill daily for 3 months to assess treatment efficacy and safety for chronic prostatitis/chronic pelvic pain syndrome.
Visits at baseline, 6 weeks, and 12 weeks
Trial Site Locations
Total: 1 location
1
G.Gennimatas General Hospital
Thessaloniki, Greece, 54636
Actively Recruiting
Research Team
I
IOANNIS MYKONIATIS, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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