None listed
Conditions
Interventions
Dietary Supplement : 1) Study product
• Active ingredient: TR-PH-EJE
• Formulation: 600 mg/capsule(500mg of TR-PH-EJE)
• Dosing: once a day, take 2 capsule (1 g/day of TR-PH-EJE)
• Duration: 12 week
Sponsors
Tricombio
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men aged over 50 years 2) IPSS(International Prostate Symptom Score) of 8 to 19 3) Serum PSA below the reference level by age • Aged 50 to 59 : 3.0 ng/mL • Aged over 60 : 4.0 ng/mL 4) Maximal urinary flow rate(Qmax) less than 15 mL/sec. 5) LUTS(Lower urinary tract symptoms) for at least 6 month 6) Participants who agree to participate and sign the informed consent
Exclusion criteria
Exclusion criteria: 1) Currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary tract, kidney and urinary, nervous, musculoskeletal, psychiatric, infectious diseases, and malignant tumors 2) Post-void residual urine volume (PVR) greater than 100 mL 3) Bladder tumor, urinary stone, urethral stricture, bladder neck contracture, inflammation of the lower urinary tract (bladder and urethra), or urinary tuberculosis 4) Gallbladder disease, Intestinal obstruction, and Cholelithiasis 5) Prostate cancer or Bladder cancer 6) History of genitourinary surgery including prostate surgery or other invasive procedures for prostate treatment (trans-urethral needle ablation, laser treatment, etc.) 7) Taken treatments for antiandrogen, luteinizing hormone releasing hormone(LHRH) analogues within 4 weeks of visit 1 8) Taken treatments for prostatic hyperplasia (5-alpha reductase inhibitors, alpha blockers, anticholinergics, beta3-adrenegic agonist, antimuscarinics, etc.) and health functional foods related to prostate health within 4 weeks of visit 1 9) Taken the following drugs within 4 weeks of visit 1 Nonsteroidal antiinflammatory drug(NSAIDs), Systemic antibiotic, Mepatricin, ACE inhibitor, Diuretic, Sympathomimetics, Histamine antagonist, Atropine, Antispasmodics, Antiparkinsonian Agents, Pseudoephedrine, Spironolactone, Corticosteroid, Calcium antagonists, Antidepressant, Chlorpheniramine 10) Drink alcohol exceeding the appropriate amount of alcohol [Men = 40 g/day (according to WHO's daily alcohol intake standards)] 11) Excessive smoke (= 20 cigarettes/day) 12) Uncontrolled hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg measured after a 10 minute rest) 13) Uncontrolled diabetes (HbA1c > 7.0% or those who have started to take drugs because of diabetes within 3 months) 14) TSH = 0.1 uIU/mL, or = 10 uIU/mL 15) Aspartate(GOT) and Alanine aminotransferase(GPT) levels = 3 times the upper limit of normal 16) Creatinine level = 2 times the upper limit of normal 17) Participation in other clinical trials within 3 months or plan to participate in other trials during this study 18) Participants who are sensitive or allergic to the food ingredients for this human application test. 19) Participants who are deemed unsuitable at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS total score after 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| IPSS total score after 6 weeks of intake;IPSS detailed item score after 6 weeks and 12 weeks of intake;Serum PSA level after 12 weeks of intake;Testosterone(Total Testosterone, Free Testosterone), DHT(Dihydrotestosterone) after 12 weeks of intake;Uroflowmetry(Peak, Average Flow Rate) after 6 weeks and 12 weeks of intake;Residual urine volume after 6 weeks and 12 weeks of intake;IIEF score after 6 weeks and 12 weeks of intake;Evaluation of improvement for human application test takers after 6 weeks and 12 weeks of intake | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Heon Kim
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed