A clinical investigation to determine the safety and efficacy of a novel, patented prunus domestica extract in benign prostatic hyperplasia (BPH)

Abstract

Background: Benign Prostate Hyperplasia (BPH) is defined as a non-cancerous enlargement of the prostate gland that is frequently observed in males over 50 years. The major symptoms of the disease involve difficulty urinating, urine dripping, incomplete bladder emptying, and, in severe cases, urine backflow that may lead to kidney infections. Conventional treatments, such as alpha-adrenergic receptor antagonists and Type 2 5-alpha reductase inhibitors, are often associated with significant side effects. In contrast, conventional drugs are based on alpha-adrenergic receptor antagonists or Type 2 5-alpha reductase inhibitors; phototherapeutics —especially phytosterols from the plum family, Prunus domestica and Prunus africana—have shown promise in BPH treatment by lowering prolactin and cholesterol levels in the prostate.

Objectives: This research aimed to conduct a robust clinical trial to evaluate the effects of Prosman™, a novel patented and standardized extract of Prunus domestica, in patients aged 40–65 suffering from BPH.

Material and Methods: An open-labeled single-armed study on 140 male patients of BPH aged 40-65 years. ProsmanTM was administered in a dosage of 100 mg twice a day for 12 weeks, with follow-ups at weeks 4, 8, and 12. Efficacy was evaluated through biochemical tests, including blood tests for Prostate-Specific Antigen (PSA), ultrasound, and urinary flow tests. Safety was assessed through analysis of various blood parameters, including hemoglobin, total leukocyte count, differential leucocyte count, SGOT, SGPT, and ALP levels, along with monitoring urea and creatinine levels.

Results: Prunus Domestica extract (ProsmanTM) was efficacious and effective in alleviating BPH in subjects, as confirmed, evidenced by a reduction in IPSS score, prostate volume, and serum PSA levels. No significant adverse changes were observed in the hematological parameters.

Conclusion: Prunus Domestica extract (ProsmanTM) can, therefore, be explored as a safe and effective phototherapeutics for the development of novel treatment procedures for BPH.

Keywords: Benign Prostatic Hyperplasia (BPH); Prunus domestica; Clinical Investigation; Urinary dysfunction, prostate enlargement; Prostate specific antigen (PSA); Ultrasound; Safety