Wpływ serenoa repens na zmniejszenie zapalenia i potrzeby ponownego biopsji u mężczyzn z łagodnym przerostem prostaty

Baseline Assessment and randomisation

After you join the study, a visit is scheduled to collect initial information. You will have a blood test that measures the PSA level (a protein that can indicate prostate activity), a magnetic resonance imaging scan (MRI) of the prostate, and questionnaires about urinary symptoms.

Based on these results, you are randomly assigned to receive either the active medication permixon or a matching placebo. the assignment is done by the study team and you are not informed which one you receive.

Start of study medication

You begin taking one hard capsule each day by mouth. The capsule contains either 320 mg of permixon (the test product) or 350 mg of macrogol 6000 (the placebo). the dose is taken once daily and continues for twelve months.

Regular follow‑up visits

Throughout the twelve‑month period you attend scheduled visits, usually every three months. During each visit the study staff checks your health, records any side effects, and may repeat the blood test for PSA.

No additional medication changes are made unless a serious problem occurs.

Mid‑study evaluation (optional)

At around six months a optional check may be performed, including a Brief Questionnaire and a repeat blood test. This step is used only to monitor safety and does not affect the study medication.

Final Assessment at 12 months

After twelve months of taking the capsule you return for a comprehensive evaluation. The evaluation includes a repeat MRI of the prostate, another blood test for PSA, and the same questionnaires that were completed at the start.

The results are used to determine whether the need for a repeat prostate biopsy has decreased.

Possible repeat prostate biopsy

If the final Assessment shows signs that a new biopsy may be necessary, you undergo a repeat prostate biopsy. This procedure involves taking small tissue samples from the prostate to be examined under a microscope.

Study completion

After the final Assessment and any required biopsy, the study participation ends. All collected data are analysed to evaluate the effect of permixon on chronic prostate inflammation.