CTRI/2024/07/071419已完成4 期
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
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 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
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Males aged 45 to 80 years (inclusive of both ages) with a diagnosis of BPH established by a surgeon/nephrologist/urologist within the last 3 months and having any one of the two clinical as well as one of the radio-diagnostic parameters:- a) Clinical parameter: i) History of lower urinary tract symptoms ii) Rectal examination indicating increased prostate size.
- •b) Radio-diagnostic parameter: i) Uroflowmetry (less than 20 ml/sec maximum flow rate [Qmax]) ii) Ultrasound Sonography (USG) – Enlargement of the central gland with a calculated urine volume exceeding 30 mL and increased post-micturition.
- •Moderate symptoms with an IPSS Score more than or equal to 8 to
- •No signs of prostate cancer as indicated by 1-3 U/L of Prostatic Acid Phosphatase (PAP) in serum.
- •Fasting blood glucose (FBG) less than 125 mg/dL.
- •Willing to give voluntary written informed consent and adhere to all the requirements of the study.
- •Note: Only biological males will be included.
- •During screening I, if participants are currently on drug/ supplement for BPH, a washout period of 10±2 days will be provided.
- •After this period, the participant will be rescheduled for screening IA.
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 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 mmHg 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/week) 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 0, Day 30, Day 60, Day 90
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 Post void residual volume (PVR) as assessed by ultrasonography(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)
研究者
Dr Shalini Srivastava
Vedic Lifesciences Pvt. Ltd.
研究点 (5)
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