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IRCT20200906048641N1 IRCT 2020-10-09 Islamic Azad University Evaluation of the effects of silymarin and calciferol on LUTS in patients with benign prostatic hyperplasia Evaluation of the effects of silymarin and calciferol on LUTS in patients with benign prostatic hyperplasia with normal and lower than normal serum vitamin D levels 2019-12-21 anticipated 60 Complete https://irct.ir/trial/50853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Referral patients who have inclusion criteria and no exclusion criteria are included in the study.After determining the patient's vitamin D level, patients are divided into two groups of normal and lower than normal vitamin D levels. Patients are randomly assigned to one of the two groups by simple random allocation method and the intervention belongs to the same group (normal group: treatment: tamsulosin tablets at a dose of 0.4 mg daily and silymarin capsules 240 mg and control group tamsulosin tablets with 0.4 mg daily and placebo capsules every 12 hours) and lower than normal group (treatment: tamsulosin tablets at a dose of 0.4 mg daily and silymarin capsules at a dose of 240 mg every 12 hours and perl calciciferol 50,000 U and the control group at a dose of tamsulosin tablets at a dose of 0.4 mg daily and placebo capsule for 12 hours receive a number and perl calciciferol (50,000 U).The randomization unit will be the patients. In each envelope, one of the four codes (A = normal therapy and code (B = normal control C) below normal therapy D) will be placed lower than normal control. Envelopes will be provided to the researcher. With each patient, one of the envelopes will be randomly selected by the researcher and introduced as a study group. The layering approach is not used. There will be no concealment in the study, Blinding description: The study is a double-blind clinical trial. The results of the study were blinded at the patient level and outcome assessments. The drug and placebo capsules were filled in the same packages with the same labeling . Only the researcher could decrypt the contents of each drug package based on the defined code. 2 Benign Prostatic Hyperplasia. Intervention 1: Patients with serum vitamin D levels receive tamsulosin tablets (Farabi Company) at a dose of 0.4 mg daily and silymarin capsules 240 mg (manufactured by Rose Pharmed Biotechnology Company) every 12 hours for 3 months. Intervention 2: Control group: Patients with serum levels of vitamin D normal, receive tamsulosin tablets(Farabi company) at a dose of 0.4 mg daily and placebo capsules every 12 hours for 3 months. Intervention 3: Intervention group: Patients with lower than normal serum levels of vitamin D, tamsulosin tablets (drug) at a dose of 0.4 mg daily and silymarin capsules 240 mg (manufactured by Rose Pharmed Farabi Company) every 12 hours and a cholecalciferol 50000 U therapeutic dose Based on serum levels, they receive vitamin D for 3 months. Intervention 4: Control group: Patients with serum vitamin D levels below normal, tamsulosin tablets (drug) at a dose of 0.4 mg daily and a placebo capsule every 12 hours and perl calciciferol 50,000 U received a therapeutic dose based on serum vitamin D levels for 3 months. Yes - There is a plan to make this available What will be shared: The paper will be publish When: 1400 To whom: researchers Conditions: email Where to obtain: college How to obtain: email to corresponging Comments:
public Dr.Mehdi Rajabi
Shariati street
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 najafinejad.fatemeh@gmail.com Islamic Azad University scientific Dr.Mehdi Rajabi
Shariati street
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 najafinejad.fatemeh@gmail.com Islamic Azad University Iran (Islamic Republic of) PSA<4 50-80 years old - mild to moderate benign prostatic hyperplasia IPSS > 8 50 years no limit Male - kidney failure - Urine retention - Prostate cancer - Liver disease - Active infection - Malignancy - Stone in urethra ,bladder , ureters - Prostate inflammation - Hematuria - History of cystoscopy - History of pelvic or urology surgery - Diabetes - Neurological diseases(Parkinson , MS , CVA ,waist disk ) - Heart failure - History of pelvic radiotherapy - History or concomitant use of antidepressant ,antihistamine , bronchodilator ,diuretic , narcotic - History of 5alpha reductase inhibitor and phosphodiesterase inhibitors drugs use - History of tuberculosis - History of urinary tract and perineum trauma - History of permanent consumption of alcohol , caffeine and excessive fluid intake - History of psychological diseases ( schizophrenia , severe depression ) History of waist - History or concomitant use of yohimbine , metronidazole , anticholinergic drugs N40.0 Enlarged prostate without lower urinary tract symptoms Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Patients with serum vitamin D levels receive tamsulosin tablets (Farabi Company) at a dose of 0.4 mg daily and silymarin capsules 240 mg (manufactured by Rose Pharmed Biotechnology Company) every 12 hours for 3 months. Control group: Patients with serum levels of vitamin D normal, receive tamsulosin tablets(Farabi company) at a dose of 0.4 mg daily and placebo capsules every 12 hours for 3 months Intervention group: Patients with lower than normal serum levels of vitamin D, tamsulosin tablets (drug) at a dose of 0.4 mg daily and silymarin capsules 240 mg (manufactured by Rose Pharmed Farabi Company) every 12 hours and a cholecalciferol 50000 U therapeutic dose Based on serum levels, they receive vitamin D for 3 months Control group: Patients with serum vitamin D levels below normal, tamsulosin tablets (drug) at a dose of 0.4 mg daily and a placebo capsule every 12 hours and perl calciciferol 50,000 U received a therapeutic dose based on serum vitamin D levels for 3 months. Improve quality of life{Description of outcome variable: prostate volume (measurement intervals at the beginning of the study / three months later). Timepoint: 1 month and 3 month. Method of measurement: How to measure the variable: ultrasound}. Changes in the severity of symptoms. Timepoint: Begin, 1 m, 3m. Method of measurement: IPSS. PSA change. Timepoint: Begin, 3m. Method of measurement: serology. - Approved 2019-12-11 Faculty of Pharmacy, Azad University Dr. Shariati St. - Gholhak - First Glacier St. Tehran Tehran Iran (Islamic Republic of)