CompletedPhase 4ACTRN12613000888763

Study of the effect of Serenoa Repens on prostatic inflammation

Does treatment with Serenoa Repens results in improvement of inflammation score compared to no treatment, in men with histologically prostatic inflammation?


Sponsor

Prof. Stavros Gravas

Enrollment

100 participants

Start Date

Jul 20, 2012

Study Type

Interventional

Conditions

Summary

The aim of the study is to determine the effect of Serenoa Repens use on prostatic inflammation, based on histological and immunohistochemical criteria. Patients with prostatic inflammation based on biopsy results are randomized to receive either Serenoa Repens 320mg/d (Group 1) or no treatment (Group 2). Patients will receive a second biopsy 6 months later. Inflammation score and immunohistochemical results, with or without treatment with Serenoa Repens, will be statistically compared, so as to evaluate the effect on the prostatic inflammation.


Eligibility

Sex: MalesMin Age: 40 YearssMax Age: 85 Yearss

Inclusion Criteria1

  • Patients with proven inflammation in prostatic biopsy

Exclusion Criteria5

  • 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.

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Interventions

Patients with prostatic inflammation based on biopsy result are randomized to receive either Serenoa Repens (oral capsules for 6 months) 320mg daily (Group 1) or no treatment (Group 2). Monitoring wil

Patients with prostatic inflammation based on biopsy result are randomized to receive either Serenoa Repens (oral capsules for 6 months) 320mg daily (Group 1) or no treatment (Group 2). Monitoring will be based on patients' tablet return.


Locations(1)

Thessaly, Greece

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ACTRN12613000888763