Study of the effect of Serenoa Repens on prostatic inflammatio

Phase 4

Completed

• Conditions: Prostatic inflammation; Alternative and Complementary Medicine - Herbal remedies; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12613000888763
• Lead Sponsor: Prof. Stavros Gravas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Patients with proven inflammation in prostatic biopsy

Exclusion Criteria

Patients who have been already treated for LUTS with herbal medication.
Patients who have been diagnosed with prostate cancer at the first biopsy.
Patients who underwent pelvic radiotherapy for any reason.
Patients with a permanent urethral catheter.
Patient with a previous TURP or intravesical instillations due to bladder cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammation score (Irani et al 1997)<br><br>[Six months after intervention]

Secondary Outcome Measures

Name	Time	Method
Immunohistochemical study of inflammation<br>- CD3, CD4, CD8 T-lymphocytes <br>- CD20 B-lymphocytes<br>- CD163 macrophages<br>The outcome will be assesed depending on prostate biopsy results. [Six months after intervention]