An interventional study of Prosman and Placebo in Healthy, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Not yet recruiting. Open to male participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Prevention
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.
All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ProsmanTM 200 mg capsule to be taken once daily for 8 weeks
Drug: Prosman
Placebo will be taken once daily for 8 weeks
Other: Placebo
Prosman, 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 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.
Time frame: 8 weeks
Total and free testosterone
To measure and compare changes in serum total and free testosterone between and within groups after 8 weeks of therapy
Time frame: 8 weeks
Quality of life (SF-12)
To measure and compare changes in quality of life between and within groups after 8 weeks of therapy
Time frame: 8 weeks
Glucose
To measure and compare changes in concentrations of glucose
Time frame: 8 weeks
Lipid profile
To measure and compare changes in lipid profile between and within groups.
Time frame: 8 weeks
Complete blood count
To measure and compare changes in Total and differential leucocyte count, Red blood cells count and Platelets count between and within groups.
Time frame: 8 weeks
Andogen deficiency subjective
To measure and compare changes in subjective measures of androgen deficiency by Androgen Deficiency in Aging Males questionnaire (ADAM) questionnaire. The ADAM questionnaire, is a screening tool used to assess potential symptoms of low testosterone in men. It's a series of yes/no questions focused on symptoms associated with androgen deficiency, such as decreased libido, fatigue, and erectile dysfunction. A positive response to the questionnaire can indicate a need for further evaluation and potential treatment for low testosterone, also known as hypogonadism between and within groups. The questionnaire typically consists of 10 questions related to symptoms like reduced libido, lack of energy, decreased strength, and erectile dysfunction. Scoring: A positive ADAM score is typically indicated by answering "yes" to question 1 or 7, or to at least three other questions. This suggests a potential need for further evaluation.
Time frame: 8 weeks
Electrolyte chemistry
To measure and compare changes in concentrations of calcium and electrolytes (sodium, potassium, chloride) in mMol/litre
Time frame: 8 weeks
Renal function tests -1
To measure and compare changes in concentrations of markers of blood urea nitrogen (BUN) and creatinine in mg/dL.
Time frame: 8 weeks
Renal function tests - 2
To measure and compare changes in concentrations of markers of total protein, and albumin IN gram/dL
Time frame: 8 weeks
Bilirubin
To measure and compare changes in concentrations of markers of liver function tests (bilirubin) in mg/dL
Time frame: 8 weeks
Liver function test
To measure and compare changes in concentrations of markers of liver function tests (alkaline phosphatase (ALP), alanine transaminase (ALT), and aspartate aminotransferase (AST)) in IU/L.
Time frame: 8 weeks
Adverse effects
To measure and compare changes in vital signs and adverse events between and within groups.
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, Bhubaneswar