Effectiveness and Safety of an Association of Phycocyanin and Palmitoylethanolamide in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Observational Multicentric Study
| Registry | NCT07013890 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 48 (Actual) |
| Sponsor | Clinica Urologica Molinette - Città della Saliute e della Scienza (Other); collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital |
| Conditions | Chronic Prostatitis (CP), Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis/ Pelvic Pain Syndrome |
| Interventions | FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium (Drug) |
| Dates | start 2022-11-02, primary completion 2023-08-15, completion 2023-09-30, first posted 2025-06-10, last updated 2025-07-24 |
| Locations | 2 sites in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Prostatitis (CP) All trials for Chronic Prostatitis With Chronic Pelvic Pain Syndrome All trials of FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.
The aim of this study was to investigate the role of an association of phycocyanin (PC) and palmitoylethanolamide (PEA) and selenium (FICOXPEA®) in male patients affected by CP/CPPS.
The main questions the present study aims to answer are:
* Does FICOXPEA® enhance quality of life of CPP/CPPS patients?
* Does it help reducing pain symptoms of CPP/CPPS patients?
Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
* Take FICOXPEA® once a day for 30 days;
* Visit the clinic for follow-up visits at 1 and 3 months;
* Answer validated questionnaires and declare potential adverse events at follow-up visits.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| FICOXPEA® | Experimental | Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium | FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg 1. capsule containing all these compounds is administered every day for 30 days |
Sex: Male, ages: 18 Years to any
Inclusion Criteria: * adult male patients (aged >18 years) * clinical affection by CP/CPPS with symptoms that persisted for ≥ 3 months; * PSA values of 4 to 10 ng/ml (at least 2 determinations) * patients must have completed diagnostic work-up, such as multiparametric prostate MRI (evidence level 1a according to EAU guidelines) with or without subsequent prostate biopsy (according to the diagnostic flow-chart depicted by EAU international guidelines). Exclusion Criteria: * patients with previous diagnosis of prostate cancer * patients who underwent previous low urinary tract surgery * patients who underwent previous intravescical chemotherapy * patients with acute bacterial prostatitis * diagnostic work-up for prostate cancer not completed * patients having antibiotic therapy or specific chronic prostatis treatment (phytotherapy included) or benign prostatic iperplasia treatment (e.g. alpha litics) at the time of the recruitment or finished less than a month before
| Facility | City | Country | Status |
|---|---|---|---|
| Molinette Hospital | Torino, Torino | Italy | |
| Dipartimento di Chirurgia Università di Catania | Catania | Italy |