Efficacy of oral silymarin formulation on prostate cancer
Phase 3
- Conditions
- on metastatic prostate cancer.Benign neoplasm of prostate
- Registration Number
- IRCT20180517039694N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Intermediate_risk prostate cancer with gleason score<8
Life expectancy more than 10 years
Exclusion Criteria
Patient with history of chemotherapy,radiotherapy or hormone therapy
Patient with chronic liver or kidney or heart disease
Patient with diabetes mellitus
Patient with autoimmune disease
History of hypersensitivity to silymarin
concomitant use of anti inflammatory drugs or other antioxidant
Patient disagreement
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Basic Prostate specific antigen serum level. Timepoint: at the beginning of the study, 2 weeks after the beginning of study, one month after the begining of the study , 6 weeks after the beginning of study and at the end of the study. Method of measurement: Serum level measurement by laboratory test.;Testosterone serum level. Timepoint: At the beginning and end of the study. Method of measurement: Serum level measurement by laboratory test.;Sex hormone binding globulin serum level. Timepoint: At the beginning and the end of the study. Method of measurement: Serum level measurement by laboratory test.;Lnsulin-like growth factor-1 serum level. Timepoint: At the beginning and the end of the study. Method of measurement: Serum level measurement by laboratory test.;Patient quality of life. Timepoint: At the end of the study. Method of measurement: Expanded Prostate Cancer Index Composite.
- Secondary Outcome Measures
Name Time Method Serum level of hepatic transaminases. Timepoint: At the beginning of the study and after one and two month. Method of measurement: Serum level measurement by laboratory test.;Creatinine Serum level. Timepoint: At the beginning of the study and after one and two month. Method of measurement: Serum level measurement by laboratory test.;Blood urea nitrogen. Timepoint: AT the beginning of the study and after one and two month. Method of measurement: Serum level measurement by laboratory test.