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| Name | Class |
|---|---|
| A.O.U. Città della Salute e della Scienza - Molinette Hospital | OTHER |
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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:
Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FICOXPEA® | Experimental | FICOXPEA® is a phytoterapic compound made of:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium | Drug | FICOXPEA® is a phytoterapic compound made of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant change of CPSI total score compared to baseline | Improvement of CP symptoms | 1 month and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant change of CPSI pain domain score compared to baseline | improvement of CP pain symptoms | 1 month and 3 months |
| Statistically significant change of CPSI QoL domain score compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
Male patients (with a prostate)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molinette Hospital | Torino | Torino | 10126 | Italy | ||
| Dipartimento di Chirurgia Università di Catania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19524353 | Result | Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brahler E, Weidner W. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study. Eur Urol. 2009 Sep;56(3):544-51. doi: 10.1016/j.eururo.2009.05.046. Epub 2009 Jun 3. | |
| 10411041 |
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prospective, observational, multicentric, single-arm study
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Improvement of CP QoL
| 1 month and 3 months |
| Statistically significant change of total PSA | Decrease of chronic altered PSA values | 1 month and 3 months |
| n° of any adverse events | number and type, so safety analysis | 1 month and 3 months |
| Catania |
| Italy |
| Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x. |
| 31937091 | Result | Sibona M, Destefanis P, Agnello M, Lillaz B, Giuliano M, Cai T, Gontero P. The association of Boswellia resin extract and propolis derived polyphenols can improve quality of life in patients affected by prostatitis-like symptoms. Arch Ital Urol Androl. 2020 Jan 14;91(4):251-255. doi: 10.4081/aiua.2019.4.251. |
| 23334883 | Result | Cai T, Luciani LG, Caola I, Mondaini N, Malossini G, Lanzafame P, Mazzoli S, Bartoletti R. Effects of pollen extract in association with vitamins (DEPROX 500(R)) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study. Urologia. 2013 Apr 24;80 Suppl 22:5-10. doi: 10.5301/RU.2013.10597. Epub 2013 Jan 16. |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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