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.
Provide voluntarily signed and dated informed consent.
Be in good health as determined by medical history and routine blood chemistries.
Age between 40 and 60 yr (inclusive).
Body Mass Index of 18.5-34.9 (inclusive).
Current neurogenic bladder dysfunction.
Current bladder neck contracture or urethral stricture.
Current acute or chronic prostatitis or UTI.
History of prostate cancer.