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Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment
NCT00680342 · View on ClinicalTrials.gov ↗
Study Summary
Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill). Eligible subjects will be randomized to treatment with placebo or one of two dosages of Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will be masked to treatment assignment. The study design includes a screening period during which patients will undergo full medical evaluation to verify protocol eligibility and a treatment period of 24 weeks during which time clinic visits and laboratory studies will be performed every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be followed for an additional 12 weeks after the completion of study medication to monitor for adverse events and investigate post-treatment outcomes. Participation in this research study requires the subject to travel to the clinic for at least 10 visits so recruitment will be limited to a geographically restricted area around participating clinical centers.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Silymarin
Study Locations (5)
Pennsylvania
- University of Pennsylvania — Philadelphia
- Thomas Jefferson University — Philadelphia
- University of Pittsburgh — Pittsburgh
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
North Carolina
- University of North Carolina — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680342
The ClinicalTrials.gov registry entry for NCT00680342 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00680342 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Massachusetts, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00680342 about?
NCT00680342 is a clinical study titled "Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment". Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this resea...
What is the current status of trial NCT00680342?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2008-04. Estimated completion is 2011-01.
What conditions does trial NCT00680342 study?
This clinical trial studies the following conditions: Chronic Hepatitis C. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00680342?
The interventions under investigation include: Placebo (OTHER), Silymarin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00680342?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00680342 being conducted?
This trial has 5 study locations across Massachusetts, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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