Lower Urinary Tract SymptomsNCT04418635
Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy
A study of Lower Urinary Tract Symptoms, run by Acrobio Healthcare Inc. at 1 site in Taiwan.
Trial summary
The aim of the study is to uses Prosta-OK® Neo that contains herb extracts including lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of nitric oxide to… Read more about this study
- Who is it for?
- Ages 30 to 55 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jun 2020to 31 Dec 2021
- 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 30 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male between the ages of 30 and 55 when signing the informed consent form
- the subject was diagnosed with mild to severe non-neurogenic lower urinary tract symptoms and planed to receive Tamsulosin therapy
- the sum of International Prostate Symptom Score (IPSS) on questions 1 to 7 was 10 points or higher
- the subject can take medication via oral or nasogastric tube confirmed with the function of absorption by the principal investigator or co-principal investigators
- the subject was willing to corporate study-related procedures and sign the informed consent form
Who cannot join
- post-void residual urine volume greater than 200 mL or peak of maximum urine flow rate less than 5 mL/s
- total serum prostate-specific antigen higher than 10 ng/mL
- bladder outlet obstruction caused by reasons other than benign prostatic hyperplasia
- lower urinary tract symptoms caused by neurological disease such as Cerebrovascular Diseases, Parkinson's, dementia, Multiple Sclerosis (MS), spinal cord injuries (SCI), cauda equina syndrome, and Peripheral Neuropathy
- history or evidence of prostate cancer, male reproductive cancers, bladder cancer, and cancer of the ureter and urethra
- history or evidence of acute urinary retention (AUR)
Show all 23Show fewer
- history or evidence of acute orthostatic hypotension
- with the urinary catheter or intermittent catheter
- stone in the urinary system
- Interstitial cystitis (IC), neurogenic bladder, overactive bladder (OAB) and Inflammatory Bowel Disease (IBD) within 3 mo prior to study entry
- chemotherapy or radiation therapy within 3 mo prior to study entry
- immunosuppressive therapy within 2 mo prior to study entry
- pelvic surgery or urinary surgery within 2 mo prior to study entry
- 5-alpha-reductase inhibitors use within 6 mo prior to entry or alpha-1-adrenergic blockers use within 2 w prior to entry
- the subject plans to use medication other than Tamsulosin such as alpha-blocker, 5-alpha-reductase inhibitors, antimuscarinic drugs, phosphodiesterase type 5 inhibitor (PDE5 inhibitors), Beta-3 agonists, desmopressin, diuretics, phenazopyridine, other drugs or foods are known to interact with tamsulosin and steroid or a nonsteroidal anti-inflammatory drug during participating in the study.
- the subject plans to receive cataract surgery during participating in the study or 1 mo after participating in the study.
- the subject took other therapies such as acupuncture or phytotherapy, including Saw Palmetto, Pygeum Africanum, Hypoxis Rooperi, Rye-pollen extract, and Pumpkin Seed extract within 2 w prior to entry.
- the subject took Chinese herbs such as Soaring Dragon Decoction, Rehmannia Right Formula, Powder for Five Types of Painful Urinary Dysfunction, Minor Bupleurum Decoction, Artemisiae Scopariae Decoction, Decoction to Enrich Yin and Direct Fire Downward, Tonifies Qi、Coptis Decoction to Relieve Toxicity and related modifications, Radix Rehmanniae, Cortex Moutan, Radix Pulsatillae, Herba Taraxaci, Herba Portulacae, Fructus Forsythiae, Flos Lonicerae, Herba Lophatheri, Fructus Gardeniae, Phellinus linteus within 7 days prior to entry.
- have a history of allergy to the ingredients of investigational product
- Serum Glutamic-Oxaloacetic Transaminase and serum Glutamic-Pyruvic Transaminase were more than three times of normal range or Serum creatinine less than 1.5 mg/dL
- have a history of substance abuse within 2 yr prior to entry
- participating in any clinical trial such as health food, herbal extracts, and drug within 30 days prior to entry
- have other significant diseases and confirmed by the principal investigator as non-eligible to be enrolled in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chiayi Chang Gung Memorial Hospital
Chiayi County, 613016
Study principal investigator, +886-5-3621-000 ext. 3191, redoxdrh@gmail.com
About this study
Official title: Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy: a Double-blind, Randomized, Placebo-controlled Trial.
The aim of the study is to uses Prosta-OK® Neo that contains herb extracts including lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of nitric oxide to explore whether Prosta-OK® can help reduce symptoms and elevate the quality of life in patients with mild to severe non-neurogenic male lower urinary tract symptoms receiving Tamsulosin therapy.
Read the detailed description
Lower urinary tract symptoms (LUTS) are kind of uncomfortable subjective feelings reported from patients and are divided into three groups, storage, voiding, and postmicturition symptoms. Many epidemiological studies have pointed out that the prevalence of LUTS among individuals aged at least 40 years in the United States, the United Kingdom, Sweden, China, Taiwan, and South Korea is up to 60%. LUTS may cause mental health disorders such as anxiety and depression and affect lifestyle that leads to a negative impact on the quality of life. In recent years, there have been numerous academic or clinical studies that assess the improvement of plant and herb extracts in LUTS.
Prosta-OK® Neo is mainly comprised of herb extracts, including lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of nitric oxide.
The aim of the study is to explore whether take Prosta-OK® 2 tablets for 85 days compared with placebo group can help reduce symptoms and elevate the quality of life in patients with mild to severe non-neurogenic male LUTS receiving Tamsulosin therapy.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Prosta-OK® Neo or Prosta-OK® Neo-matched placebo
- Keywords
- lower urinary tract symptoms, International Prostate Symptom Score, tamsulosin, adjunct therapy, herbal extractions, double-blind, randomized controlled trial
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosta-OK® Neo or Prosta-OK® Neo-matched placeboDietary supplement
the patient planed to receive Tamsulosin 0.2mg once daily is randomized to the experiment group or placebo group. After randomization, the patient received Tamsulosin therapy with Prosta-OK® Neo or Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin and Prosta-OK® Neo | Experimental | Tamsulosin 0.2mg once daily and Prosta-OK® Neo 707mg 2 tablets twice daily for 85 days Receives: Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placebo |
| Tamsulosin and Prosta-OK® Neo-matched placebo | Placebo comparator | Tamsulosin 0.2mg once daily and Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days Receives: Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in International Prostate Symptom Score from baseline on the sum of 1 to 7 questions
compare the change in International Prostate Symptom Score from baseline between the experiment group and placebo group on the sum of 1 to 7 questions that are related to voiding symptoms. Scores of 0 to 7, 8 to 19, and 20 to 35 signify mild, moderate, and severe symptoms, respectively.
Measured: day 1 (before receiving therapy) and day 85
Secondary outcomes (8)
change in International Prostate Symptom Score on questions 1, 3, and 5 that are related to voiding symptoms, questions 2, 4, and 7 that are related to storage symptoms, and question 8 that is related to the quality of life from baseline
compare the change in International Prostate Symptom Score on questions 1, 3, and 5 that are related to voiding symptoms, questions 2, 4, and 7 that are related to storage symptoms, and question 8 that is related to the quality of life from baseline between the experiment group and placebo group. A higher score is indicated more severe in symptoms.
Measured: day 1 (before receiving therapy) and day 85
change in International Prostate Symptom Score from baseline by visit on the sum of 1 to 7 questions that are related to voiding symptoms and question 8 that is related to the quality of life
compare the change in International Prostate Symptom Score from baseline by visit between the experiment group and placebo group on the sum of 1 to 7 questions that are related to voiding symptoms and question 8 that is related to the quality of life. A higher score is indicated more severe in symptoms or dissatisfaction in the quality of life.
Measured: day 1 (before receiving therapy), day 15, day 29, and day 85
change in interleukin 6, interleukin 8, tumor necrosis factor-alpha and interleukin 1 beta levels in expressed prostatic secretion from baseline by visit
compare the change in interleukin 6, interleukin 8, tumor necrosis factor-alpha and interleukin 1 beta levels in expressed prostatic secretion collected from urine after a prostate massage from baseline by visit between the experiment group and placebo group.
Measured: day 1 (before receiving therapy), day 15, day 29, and day 85
change in maximum urinary flow rate from baseline.
compare change in maximum urinary flow rate from baseline between the experiment group and placebo group.
Measured: day 1 (before receiving therapy) and day 85
change in amount of post voiding residual urine from baseline.
compare change in amount of post voiding residual urine from baseline between the experiment group and placebo group.
Measured: day 1 (before receiving therapy) and day 85
percentage of patients with adverse reaction
adverse reactions caused by the investigational product will be documented and recorded for analysis.
Measured: day 1 (after receiving therapy) to day 85
correlation of lifestyle factors on the severity of non-neurogenic male lower urinary tract symptoms assessed by the International Prostate Symptom Score
Lifestyle factors are assessed by self-designed questionnaires. The severity of non-neurogenic male lower urinary tract symptoms is assessed by the International Prostate Symptom Score, consisting of 8 questions, of which 1 to 7 questions are for evaluating the symptoms of voiding and question 8 is for evaluating the quality of life. A higher score is indicated more severe in symptoms or dissatisfaction in the quality of life.
Measured: screening visit to day 85
correlation of the other external factors on the severity of non-neurogenic male lower urinary tract symptoms assessed by the International Prostate Symptom Score
The other external factors are assessed by self-designed questionnaires. The severity of non-neurogenic male lower urinary tract symptoms is assessed by the International Prostate Symptom Score, consisting of 8 questions, of which 1 to 7 questions are for evaluating the symptoms of voiding and question 8 is for evaluating the quality of life. A higher score is indicated more severe in symptoms or dissatisfaction in the quality of life.
Measured: screening visit to day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start4 Jun 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrobio Healthcare Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Ru HO, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418635
- Sponsor's protocol ID
- LPO201910
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy: a Double-blind, Randomized, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT04418635
- Acronym / sponsor ID
- LPO201910
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- lower urinary tract symptoms, International Prostate Symptom Score, tamsulosin, adjunct therapy, herbal extractions, double-blind, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acrobio Healthcare Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Jun 2020 (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 aim of the study is to uses Prosta-OK® Neo that contains herb extracts including lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of nitric oxide to explore whether Prosta-OK® can help reduce symptoms and elevate the quality of life in patients with mild to severe non-neurogenic male lower urinary tract symptoms receiving Tamsulosin therapy.
Detailed description
Lower urinary tract symptoms (LUTS) are kind of uncomfortable subjective feelings reported from patients and are divided into three groups, storage, voiding, and postmicturition symptoms. Many epidemiological studies have pointed out that the prevalence of LUTS among individuals aged at least 40 years in the United States, the United Kingdom, Sweden, China, Taiwan, and South Korea is up to 60%. LUTS may cause mental health disorders such as anxiety and depression and affect lifestyle that leads to a negative impact on the quality of life. In recent years, there have been numerous academic or clinical studies that assess the improvement of plant and herb extracts in LUTS.
Prosta-OK® Neo is mainly comprised of herb extracts, including lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of nitric oxide.
The aim of the study is to explore whether take Prosta-OK® 2 tablets for 85 days compared with placebo group can help reduce symptoms and elevate the quality of life in patients with mild to severe non-neurogenic male LUTS receiving Tamsulosin therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin and Prosta-OK® Neo | Experimental | Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placeboTamsulosin 0.2mg once daily and Prosta-OK® Neo 707mg 2 tablets twice daily for 85 days |
| Tamsulosin and Prosta-OK® Neo-matched placebo | Placebo comparator | Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placeboTamsulosin 0.2mg once daily and Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male between the ages of 30 and 55 when signing the informed consent form
- the subject was diagnosed with mild to severe non-neurogenic lower urinary tract symptoms and planed to receive Tamsulosin therapy
- the sum of International Prostate Symptom Score (IPSS) on questions 1 to 7 was 10 points or higher
- the subject can take medication via oral or nasogastric tube confirmed with the function of absorption by the principal investigator or co-principal investigators
- the subject was willing to corporate study-related procedures and sign the informed consent form
Key exclusion criteria (23 listed)
- post-void residual urine volume greater than 200 mL or peak of maximum urine flow rate less than 5 mL/s
- total serum prostate-specific antigen higher than 10 ng/mL
- bladder outlet obstruction caused by reasons other than benign prostatic hyperplasia
- lower urinary tract symptoms caused by neurological disease such as Cerebrovascular Diseases, Parkinson's, dementia, Multiple Sclerosis (MS), spinal cord injuries (SCI), cauda equina syndrome, and Peripheral Neuropathy
- history or evidence of prostate cancer, male reproductive cancers, bladder cancer, and cancer of the ureter and urethra
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 |
|---|---|---|
| Prosta-OK® Neo or Prosta-OK® Neo-matched placebothe patient planed to receive Tamsulosin 0.2mg once daily is randomized to the experiment group or placebo group. After randomization, the patient received Tamsulosin therapy with Prosta-OK® Neo or Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days. | Dietary supplement | Tamsulosin and Prosta-OK® Neo, Tamsulosin and Prosta-OK® Neo-matched placebo |
Primary outcome
change in International Prostate Symptom Score from baseline on the sum of 1 to 7 questions
Time frame: day 1 (before receiving therapy) and day 85
compare the change in International Prostate Symptom Score from baseline between the experiment group and placebo group on the sum of 1 to 7 questions that are related to voiding symptoms. Scores of 0 to 7, 8 to 19, and 20 to 35 signify mild, moderate, and severe symptoms, respectively.
8 secondary outcomes
change in International Prostate Symptom Score on questions 1, 3, and 5 that are related to voiding symptoms, questions 2, 4, and 7 that are related to storage symptoms, and question 8 that is related to the quality of life from baseline
Time frame: day 1 (before receiving therapy) and day 85
change in International Prostate Symptom Score from baseline by visit on the sum of 1 to 7 questions that are related to voiding symptoms and question 8 that is related to the quality of life
Time frame: day 1 (before receiving therapy), day 15, day 29, and day 85
change in interleukin 6, interleukin 8, tumor necrosis factor-alpha and interleukin 1 beta levels in expressed prostatic secretion from baseline by visit
Time frame: day 1 (before receiving therapy), day 15, day 29, and day 85
change in maximum urinary flow rate from baseline.
Time frame: day 1 (before receiving therapy) and day 85
change in amount of post voiding residual urine from baseline.
Time frame: day 1 (before receiving therapy) and day 85
percentage of patients with adverse reaction
Time frame: day 1 (after receiving therapy) to day 85
correlation of lifestyle factors on the severity of non-neurogenic male lower urinary tract symptoms assessed by the International Prostate Symptom Score
Time frame: screening visit to day 85
correlation of the other external factors on the severity of non-neurogenic male lower urinary tract symptoms assessed by the International Prostate Symptom Score
Time frame: screening visit to day 85
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Dong-Ru HO, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lower Urinary Tract Symptoms, run by Acrobio Healthcare Inc. at 1 site in Taiwan.
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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Associate (+886-2-2249-1998 ext. 252, acrobio64@acrobio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in International Prostate Symptom Score from baseline on the sum of 1 to 7 questions (time frame: day 1 (before receiving therapy) and day 85). 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 5 Jun 2020.