None listed
Conditions
Interventions
Dietary Supplement : 1) Study product
• Active ingredient: HT080
• Formulation: 500 mg/tablet
• Dosing: twice a day, 2 tablets before meals (1 g/day of HT080)
• Duration: 12 week
2) Placebo
• Formu
Sponsors
NEUMED
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men aged 40 to 75 years 2) International Prostate Symptom Score of 8 to 19 3) Prostate size of = 20 g 4) Participants who agree to participate and sign the informed consent
Exclusion criteria
Exclusion criteria: 1) Currently being treated for clinically relevant acute or chronic cerebrovascular, immune, respiratory, hepatobiliary, kidney and urinary, neurological, musculoskeletal, mental, infectious, or hemato-oncological diseases (However, it is possible to participate in the trial at the investigator’s discretion considering the condition of the participants) 2) Serum PSA level = 10 ng/ml (However, those whose test results are had not been confirmed as cancer within 6 months can be enrolled) 3) Maximal urinary flow rate (Qmax) less than 5 mL/sec 4) Post-void residual urine volume (PVR) greater than 200 mL 5) Bladder tumor, urinary stone, urethral stricture, bladder neck contracture, inflammation of the lower urinary tract (bladder and urethra), or urinary tuberculosis 6) Diagnosed as prostate cancer 7) History of genitourinary surgery including prostate surgery or other invasive procedures for prostate treatment (trans-urethral needle ablation, laser treatment, etc.) 8) Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg measured after a 10-min rest) 9) Uncontrolled diabetes (fasting blood sugar level = 180 mg/dL or those who have started to take drugs because of diabetes within 3 months) 10) Thyroid diseases 11) Creatinine level = 2 times the upper limit of normal 12) Aspartate and alanine aminotransferase levels = 3 times the upper limit of normal 13) Received drugs for BPH (antimuscarinics, etc.) or functional foods within 4 weeks 14) Participation in other clinical trials within 3 months or plan to participate in other trials during this study 15) Participants who are deemed unsuitable at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| serum prostate specific antigen and testosterone levels;Serum dihydrotestosterone level;Uroflowmetry (Peak flow rate );Residual urine volume;International Index of Erectile Function;Global Response Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactWanjo Shim
Yonsei University Health System, Severance Hospital
Outcome results
None listed