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.
Parallel
Prosman
DrugProsman, the study drug is prepared from the gummy extract (pygeum) from the Indian plum tree Prunus domestica and is available in various dosage forms. Originally, pygeum, was obtained from the African prune tree bark (Prunus africanum) and was used for the treatment of various urinary problems.
Placebo
Other interventionPlacebo matched to the Prosman
Prostate health (IPSS)
To measure and compare changes in prostate health between and within groups after 8 weeks of therapy with prosmanTM The International Prostate Symptom Score (IPSS) is a questionnaire used to assess the severity of urinary symptoms in men, particularly those related to benign prostatic hyperplasia (BPH). It helps quantify the impact of these symptoms on a man's quality of life and guides treatment decisions. The IPSS consists of seven questions about urinary symptoms and one question about their impact on quality of life. Each symptom question is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The quality of life question is scored from 0 to 6, with higher scores indicating a greater negative impact on quality of life. The total IPSS score ranges from 0 to 35.
Total and free testosterone
To measure and compare changes in serum total and free testosterone between and within groups after 8 weeks of therapy
Quality of life (SF-12)
To measure and compare changes in quality of life between and within groups after 8 weeks of therapy
Glucose
To measure and compare changes in concentrations of glucose
Lipid profile
To measure and compare changes in lipid profile between and within groups.
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This trial is not recruiting at the moment. You can still explore other options:
