An open-label, single-centric, Interventional clinical study to assess the effectiveness of P Grace in the Management of Benign Prostatic Hyperplasia (BPH).
概览
- 阶段
- Post Marketing Surveillance
- 状态
- Other (Terminated)
- 发起方
- Nutra Grace
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To improve IPSS in patients of BPH
概览
简要总结
Benign Prostatic Hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland, causing bothersome urinary symptoms in men like delay in initiating micturition, hesitancy, and dribbling. For the management of BPH, medical therapy options are available with α-blockers or 5-α-reductase inhibitors, and surgery.
To reduce the risks of associated side effects with these treatment options, alternative medicines (AM) are put into use by many individuals regularly. One of these commonly used AM involves Pumpkin Seed Oil (PSO). PSO contains phytosterols, antioxidants, and essential fatty acids like Omega-3 and Omega-6, explaining its anti-inflammatory and antioxidant properties. Several preclinical and clinical studies explain PSO in potentially reducing biomarkers of BPH like PSA and alleviating the associated symptoms.
P Grace Capsules- PSO(320 mg) is administered to a total 120 subjects- One capsule twice a day along with food, in the morning and evening, consistently over 12 weeks.
Primary Study Objective: Assessment of International Prostate Symptom Score (IPSS).
Secondary Objectives:
(1) Assessing Quality of Life (QoL),
(2) changes in serum prostate specific antigen (PSA) levels,
(3) changes in maximum urine flow (Uroflowmetry), and
(4) reduction in the size of the prostate gland and prostate volume and residual urine volume using an Ultrasound scan.
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
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Aged 45 years and above male subjects.
- •Subjects must have low to moderate BPH symptoms.
- •Subjects having symptoms such as delay in initiating micturition, hesitancy, weak urinary stream, straining to void, sensation of incomplete emptying and terminal dribbling.
- •Subjects with increased residual urine volume.
- •USG prostate volume not more than 80 cc.
- •Willingness to sign the informed consent, follow the protocol, and participate in clinical trials voluntarily.
排除标准
- •Patients with malignancy, Congenital deformities of urogenital tract or any pathology other than BPH.
- •Patients with high Diabetes Mellitus Hypertension systolic 140 mm Hg or higher diastolic 90 mm Hg or higher, Renal disorders or any other systemic disease.
- •Patients planned for surgical treatment of BPH.
- •Urinary bladder calculus.
- •History of chronic prostatic diseases.
- •Patients with disturbed low BPH associated QoL scores.
- •Allergy or sensitivity to pumpkin seed oil.
结局指标
主要结局
To improve IPSS in patients of BPH
时间窗: Visit 1 Screening Visit Day 0 | Visit 2 Month 1 Week 4 | Visit 3 Month 2 Week 8 | Visit 4 Month 3 Week 12
次要结局
- To asses the change in the PSA level(Baseline and Month 3 (Week 12))
- To asses the change in the QOL(Baseline and Month 3 (WEEK 12))
- To assess the adverse events and vital signs(Baseline, Month 1 (Week 4), Month 2 (Week 8) and Month 3 (Week 12))
研究者
Dr Priyanka Mahesh
Gita Clinic