Lower Urinary Tract SymptomsNCT06677177
The Efficacy of Nano-water in Combination With Tamsulosin- Dutasteride for Lower Urinary Tract Symptoms
A study testing Nano-water, Tamsulosin Dutasteride and Regular water, tamsulosin, Dutasteride in people with Lower Urinary Tract Symptoms, run by ALI KAMAL M. SAMI at 1 site in Iraq.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Nano-water, Tamsulosin Dutasteride and Regular water, tamsulosin, Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIraq
- Study dates
- 16 Feb 2016to 19 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prostate size >30 cc and < 80 cc
- IPSS >13
Who cannot join
- High serum PSA
- Urinary tract infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Nano-water in Combination With Tamsulosin-Dutasteride for Alleviating Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia
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 .
Read more
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
Read the detailed description
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.
Patients and methods From February 2016 to November 2022, a double-blind, randomized study was carried out in Sulaimani, Iraq, in the Kurdistan region.
A questionnaire determined our patients' International Prostatic Symptom Score (IPSS). Peak urine low rates (Qmax) were calculated, and residual urine (RU) was evaluated along with an ultrasound examination of the prostate's size.
The study excluded all patients with high prostatic-specific antigens and urinary tract infections. Two groups comprising 210 men were randomly assigned for three months based on their prostate volume (>30 and < 80 ccs) and an IPSS ≥ 13 or higher. Two groups of one hundred and five men each were given different amounts of the medication: group A received Nano-water with tamsulosin-dutasteride. In contrast, Group B was given regular water with the same medication.
Unlabeled water was given in a daily dosage of 20 milliliters per kilogram of body weight-with tamsulosin 0.4 mg and finasteride 0.5 mg. At the start (baseline data) and the end of the three months, both groups underwent evaluations for the IPSS, Qmax, and RU.
The Ethics Committee of the University of Sulaimani College of Medicine authorized the current study. All individuals provided informed consent.
The statistical analysis for the study was carried out using SPSS version 24. The data were coded, tallied, and presented descriptively. Inferential data techniques, including descriptive statistics like frequency, percentage, mean, standard deviation, and the Chi-squared test, were used in the analysis. The significance of the test results was assessed using probabilistic criteria based on P-value. Specifically, a P-value of 0.05 or higher was regarded as non-significant, less than 0.001 as highly significant, and less than 0.05 as significant.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Nano-water, Tamsulosin Dutasteride, Regular water, tamsulosin, Dutasteride
- Keywords
- Lower urinary tract symptoms, benign Prostate Hyperplasia, Tamsulosin, Dutasteride, Nano-water, International Prostate Symptom Score IPSS
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-water, Tamsulosin DutasterideDietary supplement
Also called Tamsulosin, Dutasteride
Nano-water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months
Regular water, tamsulosin, DutasterideDrug
Also called Tamsulosin, Dutasteride
Regular water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Nano-water, Tamsulosin Dutasteride |
| 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 Receives: Drug: Regular water, tamsulosin, Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptoms Score IPSS
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.
Measured: From enrollment to the end of treatment at 3 months
Qmax
Qmax is the maximum flow rate of urine measure by a Flowmetry device and expressed in ml/second
Measured: From enrollment to the end of treatment at 3 months
Residual Urine
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.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start16 Feb 2016
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALI KAMAL M. SAMI
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sulaimani
- Responsible party
- Sponsor-investigator, ALI KAMAL M. SAMI, University of Sulaimani
- Investigators
- Ali K M. Sami, Principal investigator, College of Medicine, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677177
- Sponsor's protocol ID
- 574
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the social traditions here that patients do not want their private details and personal informations to be shared to other non treating doctors and they agreed to participate in this clinical trials being confirmed that the confidentiality of their personal details will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nano-water in Combination With Tamsulosin-Dutasteride for Alleviating Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06677177
- Acronym / sponsor ID
- 574
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower urinary tract symptoms, benign Prostate Hyperplasia, Tamsulosin, Dutasteride, Nano-water, International Prostate Symptom Score IPSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- ALI KAMAL M. SAMIUniversity, hospital or other
- Collaborators
- University of Sulaimani
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Patients and methods From February 2016 to November 2022, a double-blind, randomized study was carried out in Sulaimani, Iraq, in the Kurdistan region.
A questionnaire determined our patients' International Prostatic Symptom Score (IPSS). Peak urine low rates (Qmax) were calculated, and residual urine (RU) was evaluated along with an ultrasound examination of the prostate's size.
The study excluded all patients with high prostatic-specific antigens and urinary tract infections. Two groups comprising 210 men were randomly assigned for three months based on their prostate volume (>30 and < 80 ccs) and an IPSS ≥ 13 or higher. Two groups of one hundred and five men each were given different amounts of the medication: group A received Nano-water with tamsulosin-dutasteride. In contrast, Group B was given regular water with the same medication.
Unlabeled water was given in a daily dosage of 20 milliliters per kilogram of body weight-with tamsulosin 0.4 mg and finasteride 0.5 mg. At the start (baseline data) and the end of the three months, both groups underwent evaluations for the IPSS, Qmax, and RU.
The Ethics Committee of the University of Sulaimani College of Medicine authorized the current study. All individuals provided informed consent.
The statistical analysis for the study was carried out using SPSS version 24. The data were coded, tallied, and presented descriptively. Inferential data techniques, including descriptive statistics like frequency, percentage, mean, standard deviation, and the Chi-squared test, were used in the analysis. The significance of the test results was assessed using probabilistic criteria based on P-value. Specifically, a P-value of 0.05 or higher was regarded as non-significant, less than 0.001 as highly significant, and less than 0.05 as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with LUTS due to BPH/ nano-water | Experimental | Dietary Supplement: Nano-water, Tamsulosin DutasteridePatients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving nano-water combined with tamsulosin and Dutasteride |
| Patients with LUTS due to BPH/regular water | Active comparator | Drug: Regular water, tamsulosin, DutasteridePatients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving regular water combined with tamsulosin and Dutasteride |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- prostate size >30 cc and < 80 cc
- IPSS >13
Key exclusion criteria (2 listed)
- High serum PSA
- Urinary tract infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-water, Tamsulosin DutasterideAlso: Tamsulosin, DutasterideNano-water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months | Dietary supplement | Patients with LUTS due to BPH/ nano-water |
| Regular water, tamsulosin, DutasterideAlso: Tamsulosin, DutasterideRegular water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months | Drug | Patients with LUTS due to BPH/regular water |
Primary outcome
International Prostate Symptoms Score IPSS
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No. Because of the social traditions here that patients do not want their private details and personal informations to be shared to other non treating doctors and they agreed to participate in this clinical trials being confirmed that the confidentiality of their personal details will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali K M. Sami principal investigator
College of Medicine, University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-water, Tamsulosin Dutasteride and Regular water, tamsulosin, Dutasteride in people with Lower Urinary Tract Symptoms, run by ALI KAMAL M. SAMI at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptoms Score IPSS (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.