None listed
Conditions
Interventions
Dietary Supplement : Men with prostate symptoms who voluntarily signed the consent form for the human body application test are randomly assigned to the test group or the control group according to th
Sponsors
Jeonnam Bio Foundation, Jeonnam Institute of Natural Resources Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) a man over 40 years of age and under 80 years of age 2) Those with an International Prostate Symptom Score (IPSS) of 8 to 19 (Moderate) in Visit 1 and Visit 2 3) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has completed a written consent form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary systems, nervous system, musculoskeletal system, psychotropic, infectious disease, and malignant tumors (but may participate in the test according to the examiner's judgment in consideration of the condition of the subject of the human body application) 2) Those with a concentration of 4.0 ng/mL or higher of PSA (provided that the test results that are not determined to be cancerous within 3 months of visit 1 may participate in the test) 3) Those with a maximum urination rate of less than 5 mL/sec 4) Those whose residual urine volume exceeds 150 mL 5) Those who have undergone urogenital-related surgery, including prostate surgery, and other invasive procedures for prostate treatment (such as meniscus acupuncture, prostate laser treatment, etc.) 6) A person diagnosed with prostate inflammation, urinary tract infection, acute urinary retention, neurogenic cystosis, bladder tumor, urinary tract stones, urethral stenosis, bladder neck construction, lower urinary tract inflammation, urinary tract tuberculosis, prostate cancer or bladder cancer 7) Patients with bile duct obstruction, gallbladder disease including gallbladder abscess, intestinal obstruction, and cholelithiasis 8) A person who has taken antiandrogens, LH-RH analog within 4 weeks of visit 1 9) Those who have taken prostate hypertrophy drugs (5-alpha reductase inhibitors, alpha blockers, anticholinergics, antimuscarinics, etc.) and prostate health-related health functional foods within 4 weeks of visit 1 (from sopalmetto, etc.) 10) 1 4 NSAIDs, Corticosteroids, Antibiotics by systemic route, Mepartricin, ACE Inhibitor, Calcium Antagonists, Diuretics, Sympathomimetics, Antihistamines, Antidepressants, Atropine, Antispasmodic drugs, Antiparkinsonism drugs, Pseudoephedrine, Chlorpheniramine, Spironolactone 11) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 12) Those with a TSH of less than or equal to 0.1 uIU/mL, or greater than or equal to 10 uIU/mL 13) A person whose creatine is more than twice the normal upper limit of the implementation agency 14) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after stabilizing for 10 minutes in human body application test subjects) 15) Uncontrolled diabetic patients (in excess of HbA1c 10%, fasting blood sugar >180 mg/dL or new medications for diabetes within 3 months) 16) A person who has participated in another interventional clinical trial (including human-applied trials) within three months of the visit 1 or who plans to participate in another interventional clinical trial (including human-applied trials) after the start of this human-applied trial 17) A person who is sensitive or allergic to food ingredients for this human application test 18) A person who is deemed inappropriate by the tester for the human body application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS | — |
Secondary
| Measure | Time frame |
|---|---|
| blood PSA;Testosterone(Total Testosterone, Free Testosterone), DHT;Rate of urination (maximum, average);Residual Urine;Evaluation of Improvement for Subjects in Human Application Examination;Adverse Events;Clinical pathological examination (hematologic/hematochemical examination, urine test);Vital signs (blood pressure, pulse), body measurements (weight);electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public ContactSaewoong Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed