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

NCT07145034 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Prosman

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.

OTHER

Placebo

Placebo matched to the Prosman

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • Debasish Hota, DM · AIIMS, Bhubaneswar

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-07
Primary Completion
2026-05-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145034 on ClinicalTrials.gov