None listed
Conditions
Interventions
Dietary Supplement : 1. Test food I (HX109 400mg)
- Main component name: Artificial Young Lamp Complex Extract (HX109)
- Properties and Formulations: Refining in Red
- Content: 900 mg (HX109 solid con
Sponsors
Helixmith
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 and under 75 2) International Prostate Symptom Score (IPSS) is 8 to 19 (medium) points 3) A person who agrees to participate in this human body application test before the start of the human body application test and has prepared a written consent form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular system, immune system, respiratory system, hepatic system, kidney, nervous system, musculoskeletal system, mental illness, infectious disease, and malignancy (but can participate in the test at the discretion of the tester).) 2) Those with a Prostate Specific Antigen (PSA) concentration of 4.0 ng/mL or more in the blood (but those who have not been diagnosed with cancer within 3 months of visit 1 can register) 3) Those with a maximum urination rate of less than 5 mL/sec 4) Those with residual urination exceeding 150 mL 5) Those with bladder tumors, urinary tract stones, urethral stenosis, bladder neck construction, inflammation of the lower urethra (blast, urethra), urinary tract tuberculosis, prostate inflammation, urinary tract infections, acute urinary lungs, and neurogenic bladder disease within 4 weeks of visit 1 6) A person diagnosed with prostate cancer or bladder cancer 7) A person who has undergone prostate-related surgery or other invasive procedures 8) A person who has undergone a procedure or surgery that may affect lower urinary tract symptoms such as urethral incision or bladder neck stenosis incision 9) Patients with unregulated hypertension (measured after stabilization for 10 minutes, with systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, human application test subjects) 10) Patients with unregulated diabetes (hungry blood sugar above 180 mg/dL, or new drug initiation due to diabetes within 3 months) 11) People with thyroid disease 12) A person who has taken prostate hypertrophy treatments (such as 5-alpha reductase inhibitors, alpha blockers, anticholinergic drugs, antidiuretic hormones, etc.) and prostate health-related health functional foods (such as sofalmetto) 13) A person whose AST (GOT) or ALT (GPT) is three times or more than the normal upper limit of the implementing organization; 14) A person whose creatine is twice or more than the normal upper limit of the implementing organization 15) A person who has participated in other interventional clinical trials (including human application tests) within three months of visit 1, or who plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test 16) A person who is sensitive to or is allergic to the food ingredients for the human body application test 17) A person who is deemed inappropriate for the human body application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score(IPSS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood PSA Concentration;Total testosterone Concentration;Maximum urination rate;residual urine volume;IIEF(International Index of Erectile Function) score | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-hee Kang
Neonutra
Outcome results
None listed