A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score
研究概览
简要总结
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical treatment.
详细描述
The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms, prostate volume, improve the patient's quality of life and eventually to limit number of patients who require surgery or endoscopy after medical treatment. To this aim, patients who seek specialist advice for LUTS with no previous surgical treatment for BPH have been selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are significantly improved, and a reduction of prostatic volume can be observed, thus changing the usual course of the disease. All patients with BPH-related LUTS received both alphalitic and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly improved, adenoma volume and post-void residual volume were significantly reduced at 12 month. This is the first clinical experience with Iresine Celosia in BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •45 years of age or older
- •Clinically diagnosed with mild to moderate BPH
- •Prostatic volume ≥ 30 ml determined by transrectal ultrasound
- •Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml
排除标准
- •Participants must not have severe BPH (IPSS symptom score >21)
- •Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).
- •Patients must not have undergone prior transurethral resection of the prostate (TURP).
- •Post void residual (PVD) > 200 ml
- •Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
研究组 & 干预措施
odyliresin
Odyliresin (Iresine celosia) 2 ml
干预措施: Odyliresin (Dietary Supplement)
odyliresin
Odyliresin (Iresine celosia) 2 ml
干预措施: Alfuzosin (Drug)
alphalytic
alpha-antagonist (alfuzosin 10 mg)
干预措施: Odyliresin (Dietary Supplement)
alphalytic
alpha-antagonist (alfuzosin 10 mg)
干预措施: Alfuzosin (Drug)
结局指标
主要结局
International Prostate Symptom Score
时间窗: 12 months
次要结局
- Maximum flow rate(12 months)
- Residual urine volume(12 months)
- Average flow rate(12 months)
- Adenoma volume(12 months)
- adverse events(12 months)
- Quality of life score(12 months)
研究者
Daniele Porru
MD
Fondazione IRCCS Policlinico San Matteo di Pavia