A Comparative, randomized clinical trial to evaluate the efficacy & safety of Ural-BPH Capsule in adult patients with uncomplicated benign prostatic hyperplasia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- 1.Changes in uroflowmetry parameters at
研究概览
简要总结
BPH is a prevalent condition among aging males, often associated with bothersome lower urinary tract symptoms and decreased quality of life. Alpha-blockers like Tamsulosin are commonly prescribed to alleviate symptoms by relaxing smooth muscle in the prostate and bladder neck, improving urine flow and reducing lower urinary tract symptoms .
However, while alpha-blockers are effective in managing BPH symptoms, they are associated with adverse effects such as postural hypotension, ejaculatory disorders, and reduced libido, impacting participant compliance and satisfaction. Additionally, they may not address all aspects of BPH, including overactive bladder symptoms, which often coexist with BPH and contribute to the overall burden of the disease.
Given the limitations of existing therapies, there is a need for alternative treatments such as Ural-BPH Capsule, containing a proprietary blend of herbal extracts, presents a promising avenue due to its potential to target multiple aspects of BPH pathophysiology while while maintaining a favorable safety profile by potentially minimizing adverse effects associated with conventional treatments.
By conducting a comparative, randomized clinical trial, this study aims to provide robust evidence regarding the symptomatic relief, urodynamic improvement, and impact on quality of life offered by Ural-BPH Capsule compared to Tamsulosin. Additionally, the trial seeks to assess changes in sexual function, orthostatic tolerance, and safety profiles between the two treatment groups.
The study’s design includes comprehensive assessments encompassing uroflowmetry parameters, urinary symptom scores, PSA(Prostate Specific Antigen) levels, quality of life measures, and safety profiles, thereby offering a holistic evaluation of treatment efficacy and tolerability. Furthermore, the inclusion of hematological and biochemical assessments provides insights into potential systemic effects of the interventions.
Ultimately, the outcomes of this trial will contribute to evidence-based decision-making in the management of BPH, potentially offering a safer and more efficacious alternative to current therapeutic options. By addressing unmet clinical needs and optimizing participant outcomes, this study endeavors to improve the standard of care for individuals suffering from uncomplicated BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male participants aged between 40 to 80 years diagnosed with symptomatic BPH and coexisting overactive bladder symptoms (OABS), with an IPSS greater than 8, who are treatment-naive and do not wish to undergo surgery;2.Symptomatic participants of BPH (determined by IPSS/focused urological exam/Investigations) associated with any one or more of the following overactive bladder symptoms like; micturition frequency of greater than 8 per 24 hrs, nocturia episodes of greater than 2 per 24 hrs., urgency episodes of greater than 1 per 24 hrs with or without urge incontinence;3.Participants should be willing and able to complete a 4-day voiding diary (before each visit i.e., on baseline, week 2, week 4, 8, 12 and 16) and questionnaires.
排除标准
- •1.Age below 40 and above 80 years at the time of screening; 2.Participant not willing for consent for inclusion in the above study and those who cannot comply with the study protocol due to concomitant CVA, CRF, vesical stones, untreated UTI, diabetic neuropathy, uncontrolled hypertension (BP greater than 180/100), neurological disease etc.; 3.Participants of BPH with absolute indications for surgery; 4.Participants with contraindication, hypersensitivity and allergic reaction to components of investigational product and or tamsulosin hydrochloride; 5.Participants with prior history of prostatic/urethral surgery, acute or chronic prostatitis, known prostate cancer, suspected neurogenic bladder, urethral stricture and priapism; 6.Any other clinical condition which may jeopardize the study outcome or participant health in any way as per discretion of investigator.
结局指标
主要结局
1.Changes in uroflowmetry parameters at
时间窗: screening, baseline, week 2, 4,8,12 and 16(end of the study)
baseline and end of the study a)Q max (Peak flow rate) by uroflowmetry b)Percentage of participants with a 3 mL per s increase in Qmax c)Changes in average flow rate (AFR) d)Changes in the post-void residue (PVR) 2.Changes in symptomatic parameters at screening, week 2, 4,8,12 and 16. a)Changes in urinary symptoms using the American Urological Association (AUA) symptom scoring b)Changes in episodes of acute urinary retention (AUR) c)Change in International prostate symptom score (IPSS) 3.Change in Prostate Specific Antigen (PSA)
时间窗: screening, baseline, week 2, 4,8,12 and 16(end of the study)
Level (for 20 participants only) at baseline and end of the study. 4.Changes in day-time and night-time trends in urinary frequency at baseline, week 2, 4,8,12
时间窗: screening, baseline, week 2, 4,8,12 and 16(end of the study)
and 16. 5.Change in overall BPH specific quality of life scale questionnaire scores at baseline and end of the study.
时间窗: screening, baseline, week 2, 4,8,12 and 16(end of the study)
次要结局
- 1.Changes in Sexual Function Inventory Score (SFIS) at baseline, weeks 4,8,12 and 16.(2.Changes in the number of responders to positive orthostatic tests between groups at baseline, weeks 4,8,12 and 16.)
研究者
Dr Sagar Bhalerao
Lokmanya Medical Research Centre and Hospital