None listed
Conditions
Interventions
Others(Health functional food) : Subject are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational product or placebo for 12
Sponsors
Ben’s Lab
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 years of age and under 80 years of age 2) Men with mild or moderate lower urinary tract symptoms with an International Prostate Symmetom Score (IPSS) total score of 19 or less 3) A person who consented to participate in this clinical trial and signed a Informed Consent Form before the trial began.
Exclusion criteria
Exclusion criteria: 1) Those with a blood PSA (Prostate Specific Antigen) concentration greater than 4.0 ng/mL. (Provided, those who have not been determined to be cancerous within 3 months of visit 1 can be registered). 2) Those whose maximum urination rate is less than 5 mL/sec or greater than 15 mL/sec. 3) A person whose amount of residual urine exceeds 150 mL 4) A person whose prostate volume is less than 20 mL in a rigid field electrolip ultrasonic wave 5) bladder tumors, urinary stones, urethral stenosis, bladder cervical construction, lower urinary tract inflammation, urinary tuberculosis, prostate inflammation, urinary infections, acute urinary lung, neurotrophic bladder disease 6) A person diagnosed with prostate or bladder cancer 7) Those who have undergone urinary reproductive procedures, including prostate surgery, and other invasive procedures for prostate treatment (e.g., mild salivation, prostate laser treatment, etc.). 8) People who have taken prostate hypertrophy drugs (5-alpha-reducing enzyme inhibitors, alpha-blockers, anti-cholines, etc.) and health-related health-related foods (derived from Sofalmeto) within 4 weeks of visiting 1 9) Patients with uncontrolled high blood pressure (measured after 10 minutes of stabilization of those subject to human application test) with contractor blood pressure of 180 mmHg or more or relaxor blood pressure of 100 mmHg or more) 10) Uncontrolled diabetic patients (if HbA1c test results exceed 10%) 11) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the institution. 12) A person whose creatine is more than twice the normal upper limit of the institution that conducts the creatine; 13) Those who have participated in other interventional clinical trials (including human application trials) within three months of visit 1 or who plan to participate in other interventional clinical trials (including human application trials) after the start of this human application test. 14) A person who is sensitive to or allergic to food ingredients for this human body application test; 15) A person who is deemed inappropriate for the human body application test taken by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS(International Prostate Symptom Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA(Prostate Specific Antigen);Testosterone(Total Testosterone, Free Testosterone), DHT(Dihydrotestosterone); SHBG, Albumin;Peak flow rate(Qmax, Average);Amount of residual urine ;IIEF(International Index of Erectile Function);MSHQ(Male Sexual Health Questionnaire) | — |
Countries
Korea, Republic of
Contacts
Public ContactMinchul Cho
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed