Evaluation of the effects of silymarin and calciferol on LUTS in patients with benign prostatic hyperplasia

Phase 2

Conditions: Benign Prostatic Hyperplasia.
Enlarged prostate without lower urinary tract symptoms
N40.0

Registration Number: IRCT20200906048641N1

Lead Sponsor: Islamic Azad University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 60

Inclusion Criteria

PSA<4
50-80 years old -
mild to moderate benign prostatic hyperplasia
IPSS > 8

Exclusion Criteria

-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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures