A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 12
- 主要终点
- To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
研究概览
简要总结
The present study is a randomized, double-blind, placebo-controlled study. Approximately 125 individuals will be screened, and considering a screening failure rate of 20%, at least 100 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Males with no signs of inflammation as assessed by Erythrocyte Sedimentation Rate (ESR) of more than or equal to 20 mm/hr.
- •Males with more than or equal to 3.5 ng/mL of PSA in serum.
- •Males diagnosed with prostate cancer.
- •Males who have recently started a bladder-training program within the last 30 days.
- •Males who have undergone urogenital surgery.
- •Males who have had a bladder biopsy and/or cystoscopy and biopsy within the last 30 days.
- •Males who have had an indwelling catheter or practiced self-catheterization, and/or urethral stricture within the last 30 days.
- •Males diagnosed with obstructive renal/urinary tract calculi.
- •Males who have been medically diagnosed with chronic persistent local pathology (i.e., interstitial cystitis, prostatitis, etc.)
- •Males with chronic inflammatory diseases such as Rheumatoid arthritis (RA), Ulcerative colitis, and Chronic obstructive pulmonary disease (COPD).
- •Males receiving or prescribed anticoagulation therapy.
- •Males who have been diagnosed with severe renal and/or hepatic insufficiency.
- •Males who have been diagnosed with genital anatomical deformities.
- •Males with a history of uncontrolled diabetes mellitus, uncontrolled hypertension (SBP/DBP ≥ 140/90 mmHg1 with or without medication), thyroid disorders, spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
- •Males who have a history of chronic alcohol (defined as consuming more than 5 drinks on any day or more than 15 drinks/week2) and/or illicit drug abuse.
- •Males who have participated in any other clinical study during the last 30 days.
结局指标
主要结局
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
时间窗: Day 90
The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.
次要结局
- To assess the effect of IP on urinary flow rate as assessed by uroflowmetry.(Day 0, Day 90)
- To assess the effect of IP on Prostate-specific antigen (PSA) in serum(Day 0, Day 90)
- To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ)(Day 0, Day 30, Day 60, Day 90)
- To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography(Day 0, Day 90)