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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 5, 2025 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Secondary endpoints: 10 to 12v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07145034
Lead Sponsor All India Institute of Medical Sciences, Bhubaneswar
Conditions
(from sponsor)
Healthy
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov