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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000888763

Enrollment

100

Registered

2013-08-08

Start date

2012-07-20

Completion date

2014-12-22

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 will be based on patients' tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

40 Years to 85 Years

Healthy volunteers

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.

Outcome results