A Phase 4 interventional study of oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in Chronic Prostatitis (CP), Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Prostatitis/ Pelvic Pain Syndrome, sponsored by Clinica Urologica Molinette - Città della Saliute e della Scienza. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Clinica Urologica Molinette - Città della Saliute e della Scienza · Phase 4, Interventional, and Treatment
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 oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in the treatment of CP/CPPS patients. The main questions the present study aims to answer are:
Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
87 studies on the registry are indexed under Prostatitis; 9 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 69 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Clinica Urologica Molinette - Città della Saliute e della Scienza is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
It is a phytotherapic drug. The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). All these components are included in one capsule. The drug is administered for 6 months in a 1 cp/die dosage.
Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)
The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). Drug administration (1 capsule per day) for 6 months.
Also known as: PROSTYM®
Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
improvement of CP symptoms
Time frame: 6 months
Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline
improvement of CP pain symptoms
Time frame: 6 months
Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline
improvement of CP QoL
Time frame: 6 months
Total Number of Adverse Events
number and type, so safety analysis
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Clinica Urologica Molinette - Città della Saliute e della Scienza