Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life

Summary

This study is designed to test the safety and effectiveness of a plant-based supplement called Prosman™ (made from Prunus domestica extract) for men with symptoms of benign prostate hyperplasia (BPH), a common non-cancerous enlargement of the prostate gland that causes urinary problems in older men. Key Points: Purpose: The main goal is to see if Prosman™ can improve prostate health, hormone levels, and quality of life in men aged 40 to 60 who have BPH symptoms. How the Study Works: 38 men will be randomly assigned to take either Prosman™ or a placebo (a dummy pill) every day for 8 weeks. The study is randomized and controlled, meaning neither the participants nor the researchers know who is getting Prosman™ or the placebo. Measurements: Prostate health will be measured using a symptom score. Blood tests will check hormone levels and other health markers. Quality of life will also be tracked. Safety: The study will monitor for any side effects or health problems during the trial. Why It Matters: Current medications for BPH can have unwanted side effects, so there is interest in plant-based alternatives like Prosman™, which may offer benefits with fewer risks. The study follows strict ethical guidelines to protect participants' privacy and safety. Data will be kept confidential, and participants can leave the study at any time.

Timeline

Start

2025-09-07

Primary completion

2026-05-30

Completion

2026-09-30

Publications

• Background Paolone DR. Benign prostatic hyperplasia. Clin Geriatr Med. 2010 May;26(2):223-39. doi: 10.1016/j.cger.2010.02.010.
• Background Parsons JK. Modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms: new approaches to old problems. J Urol. 2007 Aug;178(2):395-401. doi: 10.1016/j.juro.2007.03.103. Epub 2007 Jun 11.
• Background Thorpe A, Neal D. Benign prostatic hyperplasia. Lancet. 2003 Apr 19;361(9366):1359-67. doi: 10.1016/S0140-6736(03)13073-5.
• Background Wilt T, Ishani A, Mac Donald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi: 10.1002/14651858.CD001044.
• Background Lees AM, Mok HY, Lees RS, McCluskey MA, Grundy SM. Plant sterols as cholesterol-lowering agents: clinical trials in patients with hypercholesterolemia and studies of sterol balance. Atherosclerosis. 1977 Nov;28(3):325-38. doi: 10.1016/0021-9150(77)90180-0.
• Background Naiyila X, Li J, Huang Y, Chen B, Zhu M, Li J, Chen Z, Yang L, Ai J, Wei Q, Liu L, Cao D. A Novel Insight into the Immune-Related Interaction of Inflammatory Cytokines in Benign Prostatic Hyperplasia. J Clin Med. 2023 Feb 24;12(5):1821. doi: 10.3390/jcm12051821.

Drugs

Indications

No indication recorded.