EUCTR2010-019668-35-IS进行中（未招募）不适用
A parallel, randomised, double blind, placebo controlled study to investigate the effect of SagaPro on nocturia in men
SagaMedica ehf.0 个研究点开始时间: 2010年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Each participant must meet the following criteria to be enrolled in this study:
- •1. Male volunteers with bothersome LUTS, 50-80 years of age.
- •2. Willing and able to complete the micturition diary and questionnaires correctly.
- •3. An average of =3 nocturnal voids per night as determined by the participant diary (average over nights of the screening period).
- •4. I-PSS total score of =8 and the I-PSS QoL score of =3.
- •5. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants who meet any of the following criteria will be excluded from the study:
- •1. Residual urine >250 ml measured by ultrasound.
- •2. Total urine output over 24 hours exceeding 3000 ml as determined by the participant diary.
- •3. Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
- •4. Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months.
- •5. History of urologic malignancy (e.g. bladder cancer, prostate cancer, etc.).
- •6. Medical history or active conditions which, in the opinion of the principal investigator (PI) would prohibit participation in the study. This includes, but is not limited to: cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (<6 months) myocardial infarction or unstable coronary artery disease.
- •7. Use of medications affecting urination (e.g. loop diuretics (furosemide), alpha blockers (including doxazosin), antimuscarinic agents, finasteride or dutasteride), or natural products used for BPH, such as saw palmetto (Sabal serrulata or Serenoa repens).
- •8. Use of SagaPro or other products containing A. archangelica within the previous 2 months prior to randomisation.
- •9. Known allergy to A. archangelica or any other ingredients of SagaPro.
- •10. Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.
- •11. Work or lifestyle potentially interfering with regular nighttime sleep, e.g. shift workers.
研究者
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