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IRCT2017091836241N2 IRCT 2017-11-02 Deputy of Research of Azad University of Pharmaceutical Sciences Evaluation of the selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor in benign prostatic hyperplasia - The study of selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor effect in patients with benign prostatic hyperplasia who are on alpha-blocker drugs and its association with PV, PVR, PSA, LUTS 2016-04-20 anticipated 60 Complete https://irct.ir/trial/27152 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random numbers. N/A Benign prostate hyperplasia. 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 before breakfast. Intervention 2: 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. Intervention 3: Control group: Capsule Tamsulosin 0.4 mg half an hour after meals once a day.
public Reza Valipour
Hospital BO-Ali Tehran, Damavand Street, Imam Hossein Square
Tehran Iran (Islamic Republic of) +98 21 3660 4854 Drrezavalipour@yahoo.com Hospital BO-Ali Tehran, Urology Clinic scientific Mahdi Rajabi
Yakhchal Street, Gholhak, Shariati
Tehran Iran (Islamic Republic of) 19419 +98 21 2260 9043 mehdirj@aol.co.uk Department of Clinical Pharmacy, Islamic Azad University, Pharmaceutical Sciences Branch Iran (Islamic Republic of) 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 5α-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 50 years no limit Male N40 Hyperplasia of prostate Treatment - Drugs Treatment - Drugs 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 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. 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. Deputy of Research of Azad University of Pharmaceutical Sciences Approved 2016-11-14 Ethics Committee of Islamic Azad University, Pharmaceutical Sciences Branch Yakhchal Street, Gholhak, Shariati Tehran Iran (Islamic Republic of)