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Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

NCT06804083 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-01-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • A.O.U. Città della Salute e della Scienza - Molinette Hospital

    collaborator OTHER

  • Clinica Urologica Molinette - Città della Saliute e della Scienza

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06804083 on ClinicalTrials.gov