None listed
Conditions
Interventions
Dietary Supplement : 1) Test food 1 (HN-550M Low Dose)
- Main component name: HN-550M
- Dosing method: 2capsules once daily
- Dose duration: 12Week (Window period +/- 5)
2) Test food 2 (HN-550M High
Sponsors
Curome Biosciences
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 years old and under 75 years of age 2) International Prostate Symptom Score (IPSS) in the range of 8 to 19) 3) Those who agree to participate in the human aptitude test and who have completed a written consent form prior to the commencement of the Clinical trial
Exclusion criteria
Exclusion criteria: 1) A person currently being treated for clinically significant acute or chronic cardiovascular relationships, immune systems, respiratory systems, gingko systems, kidney and urinary machinery, nervous systems, musculoskeletal disorders, psychotropic, infectious and blood and tumor diseases (however, it is possible to participate in the test according to the judgment of the test taker.) 2) Those with a blood prostate specific antigen (PSA) concentration greater than 4.0ng/ml (but those who have confirmed non-cancer test results within three months prior to this human testing can register) 3) Those with a maximum urination rate of less than 5 ml/s 4) Those who have a residual amount of more than 150 ml 5) bladder tumor, urinary stones, urethral stenosis, bladder construction, lower urinary tract (breathing, urethra) inflammation, urinary tuberculosis disease 6) A person diagnosed with prostate cancer or bladder cancer 7) Persons who have undergone an invasive procedure for urinary tract-related surgery 8) Persons who have undergone an surgery that may affect lower urinary tract symptoms, such as urethrectomy or cystocervical stenosis 9) Patients with unregulated hypertension (160/100mmHg or higher, measured after 10 minutes of stabilization of the test subjects) 10) Unregulated diabetic patients (in case of new drug initiation due to diabetes within 3 months or greater than 180 mg/dl per empty blood) 11) a person with thyroid disease 12) Those who have taken prostatic hypertrophy drugs and dietary supplements within 4 weeks of the start of the test 13) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the testing agency 14) Those whose creatine is more than twice the normal upper limit of the test institution 15) Persons who participated in another clinical trial within three months prior to this human testing or who plan to participate in another clinical trial during this human testing period 16) Persons who are sensitive or allergic to food related to active ingredient 17) who the Investigation finds inappropriate for this human testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate Specific Antigen, Testosterone, Dihydrotestosterone;Peak flow rate;Residual urine; International Index of Erectile Function;Adverse events;clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony) , Weight | — |
Countries
Korea, Republic of
Contacts
Public ContactARyung Jeon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed