A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of ProPlus Capsules in Subject suffering with Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1 Improvement in Total International Prostate Symptom Score (IPSS)
研究概览
简要总结
The study is designed as Prospective, Interventional, Open label, Single-centre, Single arm. Participants enrolled in this prospective, interventional, open-label, single-center, single-arm study will receive the ProPlus Capsule along with defined SoC, a formulation comprising Pumpkin seed oil, Quercetin, Vitamin D3 and Selenium. The treatment regimen is designed to assess the safety and efficacy of this capsule in individuals experiencing Benign Prostate hyperplasia (BPH). The treatment duration will be 3 months, with each participant taking 1 capsule a day (after lunch). Various parameters will be assessed including Quality of Life questionnaires, Hematology, Biochemistry, PSA level, Urine flow and Liver function. Adverse Events (AE) and Serious Adverse Events (SAE) will be monitored and documented throughout the study duration.
Visit1: Screening Visit (week 0) (-7Day)
Visit 2: Enrollment/Baseline (Week1/ Day 1)
Visit 3: Follow up Visit (week 4/Day 28 (±2 days))
Visit 4: Follow Up visit (week 8/Day 56 (±2 days))
Visit 5: EOT (week 12/Day 84 ±2 days))
Visit 6: Post Treatment Telephonic Safety Follow Up/End of Study will be
after 2 weeks followed by End of treatment: EOS (Week 14/98 (±2 days))
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1 Male Patients of age between 18 years to 65 years both inclusive who are diagnosed case of benign Prostatic Hyperplasia 2 Patients having International Prostate Symptom Score IPSS greater than or equal to 8 moderate to severe BPH at time of enrollment 3 Patients having Qmax between 5 ml per sec and 15ml per sec both included with minimum voided volume of greater than 125 ml at the time of Screening 4 Patients having post voiding residue PVR of less than 300 ml as assessed by Ultrasound at screening 5 Patient is willing to give Informed Consent.
排除标准
- •1 Prostate specific antigen (PSA) beyond 4 ng per mL at screening and enrolment 2 Patient with history of neurologic bladder urethral strictures urinary tract infections prostatitis urologic cancer and prostatic surgery 3 Patient with clinically significant bladder outflow obstruction other than BPH (calculi tumour or stricture) as judged by Investigator 4 Clinical evidence of any other bladder or urinary tract conditions which may affect lower urinary tract symptoms at screening 5 Patient undergoing hemodialysis 6 Patient who are planning for cataract or glaucoma surgery 7 Patients with history of cardiovascular disease including but not limited to History of Myocardial Infraction within the last 90 days History of angina History of congestive cardiac failure History with uncontrolled arrhythmias hypotension Blood Pressure less than 90 per 60 mm Hg uncontrolled hypertension greater than or equal to 170 per 100 mm Hg.
结局指标
主要结局
1 Improvement in Total International Prostate Symptom Score (IPSS)
时间窗: from baseline to End of treatment
2 Definition of improvement Reduction in IPSS score of ≥25%
时间窗: from baseline to End of treatment
次要结局
- 1 Improvement in maximum urinary flow rate (Qmax) & Change in Qmax(2 Evaluation of change in Total IPSS storage(Irritative) score)
研究者
Dr Upendra Kudlikar
Saikrupa Hospital