Status:
NOT_YET_RECRUITING
Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Healthy
Eligibility:
MALE
40-60 years
Phase:
NA
Brief 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),...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07145034
Start Date
September 7 2025
End Date
September 30 2026
Last Update
September 5 2025
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