A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of fenugreek extract in comparison with placebo in men with lower urinary tract symptoms and male menopausal symptoms

Daehan chemtech co., Ltd1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年6月1日最近更新: 2024年9月4日

试验速览

阶段: Phase 3 4
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: Change in the following parameters from baseline to end of treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

As lower urinary tract symptoms and benign prostatic hyperplasia (BPH) prevalence increase with age, Fenugreek seed extract presents a potential solution for both age-related androgen decline and BPH. TRT exacerbates BPH symptoms, whereas Fenugreek seed extract, by releasing bound testosterone and potentially inhibiting the conversion of testosterone to dihydrotestosterone, may offer relief to aging males affected by both conditions.[59,64]

Understanding the dual challenges of declining testosterone and increasing BPH prevalence among older men suggests a promising role for Fenugreek seed extract as a potential single treatment addressing both conditions. Research demonstrates its efficacy in addressing age-related androgen decline and suggests a possible protective role against prostate growth.

The present study is designed to confirm the efficacy and safety of Fenugreek seed extract in subjects with benign prostate hyperplasia and male menopause individuals with the study titleâ€”â€œ A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of fenugreek extract in comparison with placebo in men with lower urinary tract symptoms and male menopausal symptoms

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

年龄范围: 40.00 Year(s) 至 70.00 Year(s)（—）
性别: Male

入选标准

•Male greater than or equal to 40 to less than or equal to 70 years of age.
•Testosterone range between 3.0-5.0 ng/mL.
•At screening, subject has a IPSS greater than or equal to 8 and less than or equal to 19 AMS score greater than or equal 27 to less than or equal to 50
•Must be willing and able to give informed consent and comply with the study procedures.

排除标准

•Subjects with a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration greater than 4 ng/ml (must have prostate cancer ruled out to the satisfaction of the investigators).
•Subjects with a residual void volume of greater than 150 mL.
•Subjects with maximum urine flow rate of less than 5 mL/sec.
•Subjects with uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 100 mmHg).
•Subjects with uncontrolled diabetes (fasting blood sugar level greater than 130 mg/dL).
•Subjects who report consuming alcoholic beverages or active nicotine consumption (smoking cigarettes, vaping / ecigarettes, chewing tobacco, snuff, etc.) within the last 30 days as evidenced by self reporting.
•Subjects with BMI greater than or equal to 35kg/m
•Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal / liver and biliary tract, kidney and urinary, nervous,
•Subjects with history of neurogenic bladder dysfunction or bladder cancer.
•Subjects with acute or chronic prostatitis, urinary tract infection, hematuria, diabetes or any other chronic illness, which in the opinion of the investigator would warrant exclusion from the study or prevent the subject from completing the study.
•Subjects with bladder neck contracture or urethral stricture.
•Subjects with any serious medical comorbidity.
•Subjects with history of any prior surgery which could induce dysuria.
•Subjects with erectile dysfunction in the past 1 month.
•Subjects who are on 5alpha reductase inhibitors, alpha blockers, anticholinergics, antidiuretic hormones, antimuscarinics, or any other herbal medications (including health functional foods) for treatment of BPH and associated symptoms within 12 weeks of visit
•Subjects who are on testosterone replacement therapy (TRT) including testosterone undecanoate, testosterone enanthate, testosterone cypionate, testosterone ester, phoshodiestearase 5 (PDE 5) inhibitors, LH RH analogs, statins, fibrates, niacin, steroid, fish oil, colistin, fiber based laxatives, phytosterol margarines, anti diabetic agents, antiplatelet agents, thyroxine, diuretics, beta-blockers, any other anti-androgenic agents, treatment for erectile dysfunction (ED), or any other herbal medications (including health functional foods) for treatment of male menopause and associated symptoms within 12 weeks of visit
•Subjects who are allergic to herbal products or any component(s) of the study products.
•Subjects who are known to be HIV or hepatitis B positive or known to have any other immune compromised state.
•Subjects who are currently participating or having participated in any other clinical trial during the past 3 months prior to the beginning of this study.
•Any additional condition(s) that in the opinion of the investigators would warrant exclusion from the study or prevent the subject from completing the study.