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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180517039694N1

Enrollment

100

Registered

2018-06-13

Start date

2018-07-23

Completion date

Unknown

Last updated

2018-07-16

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

Conditions

Non metastatic prostate cancer. Benign neoplasm of prostate

Interventions

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 t

Eligibility

Sex/Gender

Male

Age

50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Intermediate_risk prostate cancer with gleason score<8 Life expectancy more than 10 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAshkan Fatemi Shandiz

Mashhad University of Medical Sciences

fatemisa931@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

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