Track topics on Twitter Track topics that are important to you
The purpose of this study is to determine if the safety, metabolism, and antioxidant activity of silymarin and green tea extract are changed when they are given in combination to patients with chronic hepatitis C infection.
Silymarin and green tea are the two most widely used botanical products used by patients with chronic hepatitis C virus (HCV) infection. A major limitation of prior clinical investigations that may account for lack of efficacy is their use of inadequate customary oral dose regimens. Ongoing Phase II studies utilizing higher than customary doses of silymarin are based on potential disease modifying effects resulting from the potent antioxidant properties of silymarin flavonolignans. Since patients often use more than one herbal product to self-treat their disease, the use of higher than customary doses of silymarin may change silymarin's potential for herbal-herbal interactions. Pharmacokinetic interactions between silymarin and green tea catechins may change their safety/tolerability profiles, and may increase their antioxidant effects through additive or synergistic pharmacodynamic interactions. The objective of this double blind, active placebo controlled, randomized clinical trial is to characterize the pharmacokinetics and to evaluate the safety, tolerability, and antioxidant effects of an herbal cocktail consisting of silymarin and epigallocatechin gallate (EGCG) standardized green tea extract in treatment-naïve patients with chronic HCV infection. This investigation will include four treatment arms that will enroll 15 subjects per arm. Subjects will be randomized to receive in a fixed sequence either: 1) 280 mg silymarin followed by the coadministration of 982.5 mg EGCG; 2) 982.5 mg EGCG followed by the coadministration of 280 mg silymarin; 3) 196.5 mg EGCG followed by the coadministration of 700 mg silymarin; or 4) 700 mg silymarin followed by the coadministration of 196.5 mg EGCG. Each dosing regimen will be administered p.o. every 12 hrs for 12 days. No treatment arm uses high doses for both silymarin and EGCG in a sequence. Depending on the treatment arm, pharmacokinetic studies will be performed on plasma concentrations for six major silymarin flavonolignans and for the green tea catechin, EGCG at the end of 12 days of either silymarin or green tea extract monotherapy (Period 1), and then again after 12 days of silymarin and green tea extract given in combination (Period 2). For each treatment arm, plasma 8F2α-isoprostane concentrations, a measure of oxidative stress, will also be determined at baseline, during each period, and then at follow-up. The results from this investigation will be used to identify doses of silymarin and green tea that can be used together safely for future efficacy trials in patients with different chronic liver diseases.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatme
Chronic Hepatitis C
silymarin, green tea extract (EGCG)
University of North Carolina at Chapel Hill- UNC Health Care
University of North Carolina, Chapel Hill
Published on BioPortfolio: 2014-07-23T21:11:44-0400
To investigate the effect of silymarin, derived from the milk thistle plant, Silybum marianum, in preventing and reversing the complications of chronic infection with hepatitis C virus and...
The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabe...
The overall objective of this project is to assess whether Silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. We will specifically compare respo...
The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acut...
RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers. PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea ...
Green tea polyphenols may contribute to the prevention of cancer and other diseases. To learn more about the pharmacokinetics and interindividual variation of green tea polyphenols after oral intake i...
Our previous experiments show that the main constituent of green-tea catechins, (-)-epigallocatechin gallate (EGCG), completely prevents tumor promotion on mouse skin initiated with 7,12-dimethylbenz(...
Epitheaflagallin (ETFG) and epitheaflagallin 3-O-gallate (ETFGg) are minor polyphenols in black tea extract that are enzymatically synthesized from epigallocatechin (EGC) and epigallocatechin gallate ...
The review discusses the effects of Epigallocatechin-3-gallate Gallate (EGCG) on glioma as a basis for future research on clinical application of EGCG. Epidemiological studies on the effects of green ...
This study aimed at examining the secretion activity of steroid hormones progesterone and 17beta-estradiol by porcine ovarian granulosa cells after addition of green tea extract. Granulosa cells were ...
INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.
INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.
INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS in conjunction with HEPATITIS B VIRUS and lasting six months or more.
A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.
A defective virus, containing particles of RNA nucleoprotein in virion-like form, present in patients with acute hepatitis B and chronic hepatitis. It requires the presence of a hepadnavirus for full replication. This is the lone species in the genus Deltavirus.
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...