The double-blind, placebo-controlled, randomized clinical trial involving 94 patients has evaluated the efficacy and safety of domestic preparation afala in patients with symptoms of I-II stages benign prostatic hyperplasia (BPH). It was shown that a 6-month course of treatment with afala at a dose of 2 tablets 4 times a day resulted in a significant reduction in the severity of urinary disorders, estimated by total IPSS score, relative to baseline values and compared to placebo therapy. The most pronounced therapeutic effects of the drug were registered in respect of irritative symptoms of BPH. According uroflowmetry, peak flow rate after 6 months of treatment was increased by more than 50%. Significant clinical benefit persisted not only within the 6-month course of therapy, but 3 months after. Long-term therapy had no effect on the concentration of total, free and complex PSA, testosterone (total and free), dihydrotestosterone, and prolactin in the blood. Absence of adverse effects, biochemical abnormalities, changes in clinical blood and urine confirmed the safety of 6-month therapy.