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IRCT20180517039694N1 IRCT 2018-06-13 Mashhad University of Medical Sciences Efficacy of oral silymarin formulation on prostate cancer Evaluating the effect of oral nano formulation of silymarin in non metastatic prostate cancer patients after radical prostatectomy 2018-07-23 anticipated 100 Complete https://irct.ir/trial/31372 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization based on prepared list by randomization.com site. Then, block randomization of four patients was used to ensure balanced allocation of eligible patients in the control and intervention arms, Blinding description: Silymarin and placebo nano formulations will fill by producer company and deliver to the oncologist. Patients who fulfilled the inclusion criteria will be selected by oncologist. He will assign them to silymarin or placebo group and give them bottles marked A or B, based on allocation sequence. Evaluation of patients during the chemotherapy course will be performed by the clinical oncologist and pharmacy student. Data collection and analysis will be carried out by the pharmacy student and the clinical pharmacist, respectively. All of them will not aware of the group allocation of the patients. 3 Non metastatic prostate cancer. Intervention 1: Intervention group: 140mg silymarin/cc four times a day and each time 1cc after meal,oral, for 8 weeks. Intervention 2: Control group: placebo for silymarin four times a day and each time 1cc after meal,oral, for 8 weeks. Yes - There is a plan to make this available What will be shared: The mentioned data will be published in an article after the completion of the study. When: The information will be available in article for ever. To whom: any one who want Conditions: Unpublished data will be accessible after agreement of all contributors and also research deputy of Mashhad University of Medical Sciences. Where to obtain: Mail to the corresponding author How to obtain: The request should be discussed with all contributors of the study and research deputy of Mashhad University of Medical Sciences. Comments:
public Ashkan Fatemi Shandiz
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 fatemisa931@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh ٍElyasi
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Intermediate_risk prostate cancer with gleason score<8 Life expectancy more than 10 years 50 years 75 years Male 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 D29.1 Benign neoplasm of prostate Treatment - Drugs Placebo Intervention group: 140mg silymarin/cc four times a day and each time 1cc after meal,oral, for 8 weeks Control group: placebo for silymarin four times a day and each time 1cc after meal,oral, for 8 weeks 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. 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. Mashhad University of Medical Sciences Approved 2018-03-17 Ethics Committee of Mashhad University of Medical Sciences Ghoreishi Building, Daneshgah Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)