Trials / Completed
CompletedNCT07013890
Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms
Effectiveness and Safety of an Association of Phycocyanin and Palmitoylethanolamide in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Observational Multicentric Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Clinica Urologica Molinette - Città della Saliute e della Scienza · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Chronic Prostatitis (CP)
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- Chronic Prostatitis/ Pelvic Pain Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 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 across 1 country: Italy
Source: ClinicalTrials.gov record NCT07013890. Inclusion in this directory is not an endorsement.