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临床试验/NCT06677177
NCT06677177已完成不适用

The Efficacy of Nano-water in Combination With Tamsulosin-Dutasteride for Alleviating Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia

ALI KAMAL M. SAMI1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
210
试验地点
1
主要终点
International Prostate Symptoms Score IPSS

研究概览

简要总结

The goal of this clinical trial is to learn if nano-water combined with tamsulosin and dutasteride can relieve the symptoms of lower urinary tract symptoms in adults with benign prostatic hyperplasia . The main questions it aims to answer are:

Does nano-water improve the results of treating patients with lower urinary tract symptoms? What is the difference between the medications alone and the medications with nano-water? Researchers will compare nano-water to a placebo (an ordinary bottled drinking water) to see if nano-water works to treat lower urinary tract symptoms .

Participants will:

Take (nano-water combined with Tamsulosin and Dutasteride) or a placebo an (ordinary bottled drinking water) combined with Tamsulosin and Dutasteride every day for 3 months Visit the clinic once every 4 weeks for checkups Keep a diary of their symptoms and the frequency of these symptoms

详细描述

Introduction Symptoms of lower urinary tract (LUT) are the most prevalent complaint among men diagnosed with benign prostatic hyperplasia (BPH). Men who have symptoms of LUT because of BPH (LUT/BPH) are more likely to seek medical attention when their symptoms become unbearable. The symptoms of LUT/BPH are usually related to voiding or storage. It has been discovered that the frequency of symptoms of LUT rises in a linear manner with age. Alpha-blockers and five alpha-reductase inhibitors have been combined to treat males with symptoms of LUT due to BPH conservatively. Structured water, a nanotechnology product, possesses unique qualities that set it apart from conventional water. Subjecting water to electromagnetic and other energy fields created and imbued it with its distinct properties.

Water that has had its molecules altered to form smaller clusters of water molecules is known as Nano-water. Conventional water comprises larger clusters of water molecules (H2O) joined by hydrogen bonds. In Nano-water, these clusters are smaller and usually comprise smaller-than-normal water structures like hexagonal or tetrahedral formations. More compact water clusters and a decrease in the propensity of water molecules to the group, often creating smaller, more stable structures-also enhanced-are the unique Nano-water components. Hydrogen Bonding: Changes to the hydrogen bonding network give the water additional structure.

Finally, improved Solubility: Minerals and other substances are more soluble due to the altered molecular arrangement. Nanotechnology, engineering, and manipulation of materials at the nanoscale (1-100 nm) provide Nano-water's potential. With this method, researchers can study and experiment with water-based nano-materials. Nano-water's unique structure is thought to improve water quality, which could have several health advantages. Among these is increased hydration due to Nano-water's smaller molecular clusters' easier passage through cell membranes, improving waste removal and nutrient transport efficiency. Studies indicate that compared to other substances, Nano-water may have a more significant potential for antioxidants. Some of its benefits are effectively combating harmful free radicals, reducing oxidative stress, and possibly reducing the risk of inflammation and chronic illnesses. Additionally, Nano-water may improve detoxification and support healthy kidney and liver function by more efficiently binding to toxins and heavy metals. It shows it induces better Circulation: Because Nano-water is said to have a lower viscosity, blood flow may be enhanced, resulting in more effective delivery of nutrients and oxygen to tissues and organs.

Water structured by nanotechnology: Magnalife is produced by modulators., particular energy fields, and frequencies that change regular water into Nano-water.

The study aimed to assess the effectiveness of Nano-water doubled with tamsulosin-dutasteride in improving symptoms of LUT in BPH patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • prostate size >30 cc and < 80 cc
  • IPSS >13

排除标准

  • High serum PSA
  • Urinary tract infections

研究组 & 干预措施

Patients with LUTS due to BPH/ nano-water

Experimental

Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving nano-water combined with tamsulosin and Dutasteride

干预措施: Nano-water, Tamsulosin Dutasteride (Dietary Supplement)

Patients with LUTS due to BPH/regular water

Active Comparator

Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving regular water combined with tamsulosin and Dutasteride

干预措施: Regular water, tamsulosin, Dutasteride (Drug)

结局指标

主要结局

International Prostate Symptoms Score IPSS

时间窗: From enrollment to the end of treatment at 3 months

International Prostate Symptoms Score IPSS include 7 questions , to which each question is given a number of 1-5 , these questions include: Frequency, Urgency, Hesitancy, Nocturia, Incomplete emptying, Weak stream, Straining.

Qmax

时间窗: From enrollment to the end of treatment at 3 months

Qmax is the maximum flow rate of urine measure by a Flowmetry device and expressed in ml/second

Residual Urine

时间窗: From enrollment to the end of treatment at 3 months

Residual Urine is the post-voiding residual volume of urine remaining in the urinary bladder after voiding, measure by an ultrasound machine and expressed in ml.

次要结局

未报告次要终点

研究者

发起方
ALI KAMAL M. SAMI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ALI KAMAL M. SAMI

Lecturer , Urology , Department of Surgery, College of Medicine, Medical Doctor

University of Sulaimani

研究点 (1)

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