Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
RecruitingNot applicableNCT07629505
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) has a huge socioeconomic impact.Presently, a ''scientific dead-end'' regarding effective treatment of CP/CPPS is reported. Promising results of clinical studies, regardless their limitations, upon efficacy of phytotherapy for CP/CPPS patients have been published .Phytotherapy is cost effective and avoids the systemic side effects of other treatments being a therapy with the possibility of repeating the treatment protocol at any time. Certain important issues, regarding the efficacy and safety of phytotherapy, remain to be answered thus investing scientifically and economically to the concept of phytotherapy for CP/CPPS, definitively seems to be a move to the right direction. In this concept we will conduct a double-blind placebo-controlled randomized clinical trial assessing treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy for CP/CPPS 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 CP/CPPS 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 CP/CPPS diagnosis will participate in this study. Inclusion and exclusion criteria Inclusion criteria: 1. Participant must be between 18 and 50 years old. 2. Participant has signed and dated the appropriate Informed Consent document. 3. Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months. Exclusion criteria: 1. Participant …
Study details
- Official title
- 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.
- Conditions
- Chronic Pelvic Pain Syndrome (CPPS)
- Interventions
- Dietary supplement: Oxiblume:CoQ10 (Ralivia) therapy
- Other: Placebo Pill.
- Sponsor
- G.Gennimatas General Hospital
- Start date
- 2026-06-08
- Primary completion
- 2026-12
- Sex
- Male
- Age range
- from 18 Years to 50 Years
- Results posted
- No results posted in this snapshot
- Countries
- Greece
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant must be between 18 and 50 years old. 2. Participant has signed and dated the appropriate Informed Consent document. 3. Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months. Exclusion Criteria: 1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). 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 associated with LUTS, any neurological disease or disorder affecting the bladder. 6. Participant has undergone prostate surgery or treatment. 7. Participant with penile or urinary sphincter implants. 8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis. 9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07629505