20 mg/kg Silibinin (Legalon SIL) ,as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.

Placebo (saline), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.

Hepatitis C Virus Recurrence

20 mg/kg Silibinin (Legalon SIL), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.

Silibinin (Legalon-SIL)

Saline

Azienda Ospedaliero-Universitaria Policlinico Consorziale

Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of LEGALON SIL for the Treatment of HCV Recurrence in Stable Liver Transplanted Patients

To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.

To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load and lymphocyte activation one year after the beginning of treatment.

To determine the effect of post-transplant treatment with Legalon SIL on fibrosis and functional state.

To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.

Rottapharm

Azienda Ospedaliera Universitaria Policlinico

Patients will receive green tea extract and milk thistle extract supplements for one week prior to surgery and for 30 days after surgery.

Colon Cancer

Green Tea Extract: 3,200 mg per day Milk thistle extract with phosphatidylcholine: 2,700 mg per day

Green Tea and Milk Thistle Supplements

Mount Sinai St. Luke's Roosevelt Hospital Center

Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection

Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study

Richard Whelan

Professor

St. Luke's-Roosevelt Hospital Center

Subjects in this group will take Silibin-Phytosome 13 grams daily, in three divided doses for 2-10 weeks.

Patients in this arm will not take any intervention.

Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.

Silibin-Phytosome

Subjects in the control arm did not receive any treatment or placebo.

Control

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.

Measurable Silibinin Tissue Levels

Overall Study

Dr. Thomas Flaig

Prostate Cancer

Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.

Genitourinary care team at the University of Colorado

silibinin/rak

Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients

Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection

The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer

Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy

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