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

Обзор

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.

Вмешательства

• Препарат 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.
• Другое Placebo
  Placebo matched to the Prosman

Первичные конечные точки

• Prostate health (IPSS) [Срок оценки: 8 weeks]

Вторичные конечные точки (12)

• Total and free testosterone [Срок оценки: 8 weeks]
• Quality of life (SF-12) [Срок оценки: 8 weeks]
• Glucose [Срок оценки: 8 weeks]
• Lipid profile [Срок оценки: 8 weeks]
• Complete blood count [Срок оценки: 8 weeks]
• Andogen deficiency subjective [Срок оценки: 8 weeks]
• Electrolyte chemistry [Срок оценки: 8 weeks]
• Renal function tests -1 [Срок оценки: 8 weeks]
• Renal function tests - 2 [Срок оценки: 8 weeks]
• Bilirubin [Срок оценки: 8 weeks]
• Liver function test [Срок оценки: 8 weeks]
• Adverse effects [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Paolone DR. Benign prostatic hyperplasia. Clin Geriatr Med. 2010 May;26(2):223-39. doi: 10.1016/j.cger.2010.02.010. PMID 20497842
• Parsons JK. Modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms: new approaches to old problems. J Urol. 2007 Aug;178(2):395-401. doi: 10.1016/j.juro.2007.03.103. Epub 2007 Jun 11. PMID 17561143
• Thorpe A, Neal D. Benign prostatic hyperplasia. Lancet. 2003 Apr 19;361(9366):1359-67. doi: 10.1016/S0140-6736(03)13073-5. PMID 12711484
• Wilt T, Ishani A, Mac Donald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi: 10.1002/14651858.CD001044. PMID 11869585
• Lees AM, Mok HY, Lees RS, McCluskey MA, Grundy SM. Plant sterols as cholesterol-lowering agents: clinical trials in patients with hypercholesterolemia and studies of sterol balance. Atherosclerosis. 1977 Nov;28(3):325-38. doi: 10.1016/0021-9150(77)90180-0. PMID 597345
• Naiyila X, Li J, Huang Y, Chen B, Zhu M, Li J, Chen Z, Yang L, Ai J, Wei Q, Liu L, Cao D. A Novel Insight into the Immune-Related Interaction of Inflammatory Cytokines in Benign Prostatic Hyperplasia. J Clin Med. 2023 Feb 24;12(5):1821. doi: 10.3390/jcm12051821. PMID 36902608

Идентификаторы

NCT: NCT07145034 · T/IM-NF/Pharm/25-26/30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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