None listed
Conditions
Interventions
Drug : 1) Control group: tamsulosin 0.2mg (Harnal®D 0.2mg, 1 time a day) + placebo 9gm (three times a day, each 3gm)
2) A group : tamsulosin 0.2 mg (Harnal®D 0.2mg, 1 time a day) + Hachimijiogan gran
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Men over 45 years of age ? The International Prostate Symptom Score (IPSS) score is 8 points (moderate) or higher ? The minimum urine volume is over 120cc and the Qmax is 5 ~ 15 ml/s ? If the cause of lower urinary tract symptoms is enlarged prostate ? Patients who can understand the nature and risks and benefits of treatment and research, and sign a consent form to participate in the clinical trial after sufficient discussion
Exclusion criteria
Exclusion criteria: ? Patients who need to undergo surgery during the study period or immediately ? Patients with previous history of prostatectomy or urethroplasty ? Patients with severe renal impairment (serum creatinine level> 2.0 mg/dl) ? Patients with liver function impairment (when serum GOT and GTP levels are over 100 U/L) ? Patients who experienced prior orthostatic hypotension or syncope due to alpha blocker ? Patients who are hypersensitive or contraindicated in this study drug ? Patients with prostate cancer, bladder cancer, etc. ? Patients with urethral stricture ? Patients keep the indwelling catheter or urinate with an intermittent self-catheter ? Patients with neurological disease or spinal disease that may affect urination symptoms ? Patient whom other researcher judges as inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS) and Quality of Life (QoL) - Comparison of IPSS total score, changes of storage symptoms, voiding symptoms and quality of life improvement after administration;BSW (Benefit, satisfaction, willingness to continue) score;Uro-flow meter & residual urine, Qmax, PVR;Changes in prostate size by transrectal ultrasound (TRUS);Voiding diary;Body Pattern Question;NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure change;Prostate specific antigen test (PSA);BUN, Creatinine, AST, ALT;Urine microscopy RBC, WBC | — |
Countries
Korea, Republic of
Contacts
Public ContactJuhyun Shin
Chungnam National University Hospital
Outcome results
None listed