None listed
Conditions
Interventions
Dietary Supplement : 1) Study product
• Active ingredient: HFN2-007
• Formulation: 500 mg/capsule
• Dosing: twice a day (30 minutes after breakfast and dinner), take 2 capsules at once with water (1,2
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Males aged 40 years or older and 75 years or younger 2) Those with an International Prostate Symptom Score of 8 to 19 points in Visit 1 and Visit 2 3) Those who agreed to participate in this human application test and completed a written consent form (Informed Consent Form) before the start of the human application test
Exclusion criteria
Exclusion criteria: 1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, nervous, musculoskeletal, psychiatric, infectious diseases, and malignant tumors (however, participation in the test may be made at the investigator's discretion, considering the condition of the subject of the human application test) 2) Those with a blood Prostate Specific Antigen concentration of 4.0 ng/mL or higher (however, those who have not been diagnosed with cancer within 3 months of Visit 1 may participate in the test) 3) Those with a maximum urination speed of less than 5 mL/sec 4) Those with residual urine volume exceeding 150 mL 5) Those who have undergone urinary-genitourinary surgery, including prostate surgery, or other invasive procedures for prostate treatment (transurethral acupuncture, prostate laser treatment, etc.) 6) Prostatitis, urinary tract infection, acute urinary retention, neurogenic cystitis, bladder tumor, urinary stones, urethral stricture, bladder neck contracture, Those diagnosed with lower urinary tract inflammation, urinary tract tuberculosis, prostate cancer, or bladder cancer 7) Those with gallbladder disease including biliary tract obstruction, gallbladder abscess, intestinal obstruction, or cholelithiasis 8) Those who took anti-androgens, luteinizing hormone, or luteinizing hormone-releasing hormone (LHRH) analogues within 4 weeks of Visit 1 9) Those who took prostate hypertrophy treatment (5-alpha reductase inhibitors, alpha blockers, anticholinergics, antimuscarinics, etc.) and prostate health-related health functional foods (saw palmetto-derived, etc.) within 4 weeks of Visit 1 10) Those who took nonsteroidal anti-inflammatory drugs, corticosteroids, systemic antibiotics, mephatricin, ACE inhibitors, calcium channel blockers, diuretics, sympathomimetics, antihistamines, antidepressants, atropine, antispasmodics, antiparkinsonian agents, pseudoephedrine, chlorpheniramine or spironolactone within 4 weeks from visit 1 11) Those whose AST (GOT) or ALT (GPT) was 3 times or more the upper limit of normal in the testing institution 12) Those whose creatinine was 2 times or more the upper limit of normal in the testing institution 13) Those whose TSH was 0.1 uIU/mL or less or 10 uIU/mL or more 14) Those with uncontrolled hypertension (systolic blood pressure 160 mmHg or more or diastolic blood pressure 100 mmHg or more, based on measurements taken after 10 minutes of rest in subjects of human application trials) 15) Those with uncontrolled diabetes (HbA1c exceeding 10%, fasting blood sugar 180 mg/dL or more, or those who started taking medication for diabetes within 3 months) 16) Those who participated in another interventional clinical trial (including human application trials) within 3 months of Visit 1 or those who participated in another interventional clinical trial after the start of this human application trial Those who plan to participate in clinical trials (including human application trials) 17) Those who are sensitive or allergic to food ingredients used in this human application trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| blood Prostate Specific Antigen;Testosterone(Total Testosterone, Free Testosterone), dihydrotestosterone;Uroflowmetry(Peak, Average Flow Rate) ;Residual urine volume;International Index of Erectile Function ;Evaluation of Improvement for Subjects in Human Application Examination | — |
Countries
Korea, Republic of
Contacts
Public ContactSae Woong Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed