Trials / Completed
CompletedNCT06804083
Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.
Oral Immunoglobulins From Bovine Colostrum and Anti-inflammatory Extracts in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (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 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: * Does PROSTYM® enhance quality of life of CPP/CPPS patients? * Does it help reducing pain symptoms of CPP/CPPS patients? Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy. Participants will: * Take PROSTYM® every day for 6 months; * Visit the clinic for follow-up visits at 3 and 6 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 | 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. |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2022-12-31
- Completion
- 2023-06-30
- First posted
- 2025-01-31
- Last updated
- 2025-01-31
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06804083. Inclusion in this directory is not an endorsement.