Benign prostate hyperplasia. Hyperplasia of prostate
Conditions
Interventions
Intervention 1: Intervention group 1: Capsule Tamsulosin 0.4 mg half an hour after meals once a day plus capsule Celecoxib 200 mg with food once a day plus capsule Omeprazole 20 mg half an hour befor
Treatment - Drugs
Intervention group 1: Capsule Tamsulosin 0.4 mg half an hour after meals once a day plus capsule Celecoxib 200 mg with food once a day plus capsule Omeprazole 20 mg half an hour before breakfast
Intervention group 2: Capsule Tamsulosin 0.4 mg half an hour after meals once a day plus Tablet Naproxen 500 mg with food once a day plus capsule Omeprazole 20 mg half an hour before breakfast
Control group: Capsule Tamsulosin 0.4 mg half an hour after meals once a day
Sponsors
Deputy of Research of Azad University of Pharmaceutical Sciences
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: Men over the age of 50 who have moderate to severe benign prostatic hyperplasia with international prostate symptoms score greater than 8; benign prostate diagnosis; no Liver problem; no active infections; no history of frequent urinary tract infections; no clear malignancy; no stone in the urethra, ureter and bladder; no history of urolithiasis; no prostate transurethral removal; no history of inflammation of the prostate; absence of a microscopy hematuria and advanced; no history of or retention; no history of trauma of the lower back and perineal and urethra; no history of cystoscopy; no history of sexually transmitted infections; no history of pelvic or urological surgery; non diabetic; non-neurological diseases (CNA, Parkinson's disease, MS and lumbar disks); history of congestive heart failure; no history of pelvic radiotherapy; no history of tuberculosis; no renal failure with creatinine higher than 1.3; no history of antidepressants, antihistamines, bronchodilators, diuretics and narcotics in the last 3 months; no history of psychological diseases (such as Schizopherenia, severe depression); lack of experience in the use of effective drugs in the treatment of benign prostatic hypertrophy in the last 3 months, including 5a-alpha-reductates and alpha-blockers, and phosphodiesterase inhibitors; no history of persistent alcohol and caffeine intake; high fluid intake; gastrointestinal ulcer or gastrointestinal bleeding. Exclusion criteria: Patient disagreement; unwillingness to follow up the study program for any reason; sensitivity to the drug and its ingredients? the use of the drug causes patient dissatisfaction; the acute urinary problems so that the person has urinary retention and the condition is so severe that it requires catheterization and surgery; prostate cancer
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: questionnaire.;Quality of life. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate Specific Antigen. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Blood test.;Prostate Volume. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Abdominal ultrasound.;Post-Void Residual Urine Volume. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Abdominal ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Valipour
Hospital BO-Ali Tehran, Urology Clinic
Outcome results
None listed