A clinical investigation to determine the safety and efficacy of a novel, patented prunus domestica extract in benign prostatic hyperplasia (BPH) | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 15 No. 2 (2025): February 2025 / Research Articles A clinical investigation to determine the safety and efficacy of a novel, patented prunus domestica extract in benign prostatic hyperplasia (BPH) Authors S.N. Sankhwar Narsingh Verma Naresh Patel Pawan Kumar Apurva Goel Mehul Rungta DOI: https://doi.org/10.31989/ffhd.v15i2.1556 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 Downloads [Abstract] [Full Article] Published 2025-03-01 Issue Vol. 15 No. 2 (2025): February 2025 Section Research Articles License Copyright (c) 2025 Functional Foods in Health and Disease This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com