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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200906048641N1
Enrollment
60
Registered
2020-10-09
Start date
2019-12-21
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia. Enlarged prostate without lower urinary tract symptoms

Interventions

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 Com

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: PSA 8

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mehdi Rajabi

Islamic Azad University

najafinejad.fatemeh@gmail.com+98 21 2264 0051

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026