Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.
NCT ID: NCT06804083
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2020-03-01
2023-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PROSTYM®
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinical affection by CP/CPPS with symptoms that persisted for ≥6 months;
* CPSI pain domain score ≥5 points;
* negative Meares and Stamey test score.
Exclusion Criteria
* no other drug or supplement specific to chronic prostatitis in the previous 30 days.
18 Years
MALE
No
Sponsors
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A.O.U. Città della Salute e della Scienza - Molinette Hospital
OTHER
Clinica Urologica Molinette - Città della Saliute e della Scienza
OTHER
Responsible Party
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Mattia Sibona
Urologist, MD
Locations
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Molinette Hospital
Torino, Torino, Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CET n. 00054/2019
Identifier Type: -
Identifier Source: org_study_id