None listed
Conditions
Interventions
Others(Health functional food) : Subject are randomly assigned to test group?, test group? or the control group according to the registered order. Subjects take investigational product or placebo for
Sponsors
Kwang Dong Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 years of age and under 75 years of age 2) Men with an International Prostate Symmetom Score (IPSS) total score of 12~19 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) A person currently undergoing treatment for severe cardiovascular system, immune system, respiratory system, liver system, kidney, nervous system, musculoskeletal system, mental illness, infectious disease, and malignancy (but may participate in the test at the discretion of the Investigator) 2) 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). 3) Those whose maximum urination rate is less than 5 mL/sec 4) A person whose amount of residual urine exceeds 150 mL 5) A person who has 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., Trans-Urethral Needle Ablation Of the Prostate, Prostate laser treatment, etc.). 8) Patients with uncontrolled high blood pressure (measured after 10 minutes of stabilization of those subject to human application test) with contractor blood pressure of 160 mmHg or more or relaxor blood pressure of 100 mmHg or more) 9) Patients with diabetic disease (if HbA1c test results exceed 10%, fasting blood sugar of 180 mg/dL or more or new drug initiation due to diabetes within 3 months of visit 1) 10) A person who has thyroid disease 11) People who have taken prostate hypertrophy drugs (5-alpha-reducing enzyme inhibitors, alpha-blockers, anti-cholines, antidiuretic hormone drug, etc.) and health-related health-related foods (derived from Sofalmeto) within 4 weeks of visiting 1 12) A person whose AST(GOT) or ALT(GPT) is more than three times the normal upper limit of the institution. 13) A person whose creatine is more than twice the normal upper limit of the institution. 14) 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. 15) A person who is sensitive to or allergic to food ingredients for this human body application test; 16) A person who is deemed inappropriate for the human body application test taken by the Investigator
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);Peak flow rate(Qmax, Average);Amount of residual urine ;IIEF(International Index of Erectile Function) | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-sup Lee
The Catholic University of Korea
Outcome results
None listed