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

All India Institute of Medical Sciences, Bhubaneswar

Status: Not yet enrolling

Conditions: Healthy

Treatments: Other: Placebo; Drug: Prosman

Study type: Interventional

Funder types: Other

Identifiers

NCT07145034

T/IM-NF/Pharm/25-26/30

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).
• Body weight of at least 55 kg.
• An IPSS score of 8-19 (inclusive).
• Symptoms of benign prostatic hyperplasia (BPH) for at least 6 months prior to screening (e.g. Incomplete emptying: the feeling the bladder is full, even after passing urine; Frequency: the need to pass urine often, about every one to two hours; Intermittency: the need to stop and start several times when passing urine; Urgency: feeling the urgent need to pass urine; Weak stream: a weak urine flow; Straining: trouble starting to pass urine or the need to push or strain to pass urine; Nocturia: the need to wake up at night more than two times to pass urine.
• Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• The subject is willing and able to comply with the study protocol.

Exclusion criteria

• Current neurogenic bladder dysfunction.
• Current bladder neck contracture or urethral stricture.
• Current acute or chronic prostatitis or UTI.
• History of prostate cancer.
• Use of any other herbal medication for the treatment of BPH, associated symptoms, and erectile dysfunction within the past month.
• Current hematuria of unknown etiology.
• History of radiotherapy.
• History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
• History of diabetes or endocrine disorder.
• History of use of medications or dietary supplements known to confound the study or its endpoints.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
• Current smokers or smoking within the past month.
• History of hyperparathyroidism or an untreated thyroid condition.
• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Known sensitivity to any ingredient in the test formulations as listed in the product label.
• Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
• Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Prosman

Experimental group

Description:

ProsmanTM 200 mg capsule to be taken once daily for 8 weeks

Treatment:

Drug: Prosman

Placebo

Placebo Comparator group

Description:

Placebo will be taken once daily for 8 weeks

Treatment:

Other: Placebo