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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00389376 |
The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.
Condition | Intervention | Phase |
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Hepatitis C Non-Alcoholic Fatty Liver Disease |
Drug: Placebo Drug: Silymarin |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease |
Enrollment: | 56 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1
Placebo and 140 mg single dose + every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
140 mg every 8 hours
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Group 2
Placebo and 280 mg single dose
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Drug: Placebo
Placebo
Drug: Silymarin
280 mg single dose
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Group 3
Placebo and 280mg every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
280 mg every 8 hours
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Group 4
Placebo and 280 single dose + every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
280 mg single dose + every 8 hours
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Group 5
Placebo and 560 mg single dose + every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
560 mg single dose + every 8 hours
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Group 6
Placebo and 560 mg single dose + every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
560 mg single dose + every 8 hours
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Group 7
Placebo and 700 mg single dose + every 8 hours
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Drug: Placebo
Placebo
Drug: Silymarin
700 mg single dose + every 8 hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Subjects will be eligible for enrollment in this study if they meet the following criteria:
Exclusion criteria
Subjects with any of the following will not be eligible for participation:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, North Carolina | |
The University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
University of Pittsburgh, Graduate School of Public Health | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | K. Rajender Reddy, MD | University of Pennsylvania |
Principal Investigator: | Victor Navarro, MD | Thomas Jefferson University |
Principal Investigator: | Nezam Afdhal, MD | Beth Isreal Deaconess Medical Center |
Principal Investigator: | Michael Fried, MD | University of North Carolina |
Responsible Party: | NCCAM/NIDDK/UNC/UPenn/TJU/BIDMC/UPitt ( SyNCH Steering Committee ) |
Study ID Numbers: | U01 AT003566-01, NIH grant # U01-AT0035661 |
Study First Received: | October 16, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00389376 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Hepatitis, Chronic |
Silymarin Hepatitis, Viral, Human Fatty Liver Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Antioxidants Molecular Mechanisms of Pharmacological Action Flaviviridae Infections |
Physiological Effects of Drugs Protective Agents Pharmacologic Actions |