Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT04418635
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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 QićCoptis 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT04418635
Study Brief:
Protocol Section:
NCT04418635