Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Prostate health (IPSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prosman
ProsmanTM 200 mg capsule to be taken once daily for 8 weeks
干预措施: Prosman (Drug)
Placebo
Placebo will be taken once daily for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Prostate health (IPSS)
时间窗: 8 weeks
To measure and compare changes in prostate health between and within groups after 8 weeks of therapy with prosmanTM The International Prostate Symptom Score (IPSS) is a questionnaire used to assess the severity of urinary symptoms in men, particularly those related to benign prostatic hyperplasia (BPH). It helps quantify the impact of these symptoms on a man's quality of life and guides treatment decisions. The IPSS consists of seven questions about urinary symptoms and one question about their impact on quality of life. Each symptom question is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The quality of life question is scored from 0 to 6, with higher scores indicating a greater negative impact on quality of life. The total IPSS score ranges from 0 to 35.
次要结局
- Glucose(8 weeks)
- Total and free testosterone(8 weeks)
- Renal function tests -1(8 weeks)
- Bilirubin(8 weeks)
- Quality of life (SF-12)(8 weeks)
- Lipid profile(8 weeks)
- Complete blood count(8 weeks)
- Andogen deficiency subjective(8 weeks)
- Electrolyte chemistry(8 weeks)
- Renal function tests - 2(8 weeks)
- Liver function test(8 weeks)
- Adverse effects(8 weeks)
研究者
Dr Debasish Hota
Professor
All India Institute of Medical Sciences, Bhubaneswar