- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030030
Evaluating Silymarin for Chronic Hepatitis C
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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/or clearing hepatitis C infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this exploratory project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum marianum, in preventing and reversing the complications of chronic infection with HCV and/or clearing HCV infections, thereby generating preliminary results to serve as the basis of a more definitive study.
Allopathic therapeutic interventions have not proved promising, particularly with the genotype most commonly encountered in Egypt and they are prohibitively expensive in the developing world.
Egypt has the highest prevalence of HCV infection in the world, averaging 15-25% in rural communities.
There are limited rigorous assessments of the dietary supplement milk thistle, but there is promise of salutary effect.
The specific aims are to evaluate whether silymarin, the extract of milk thistle, can: (1) improves hepatic morbidity in subjects with chronic HCV hepatitis and/or cirrhosis; (2) prevent progression of liver disease in participants who have chronic HCV infections but who have normal liver enzyme levels; (3) help clear HCV infections; and (4) improves these participants' quality of life.
Participants will be randomly assigned to receive silymarin or a vitamin supplement (below antioxidant levels).
Participants will be recruited from a cohort of HCV-infected individuals currently enrolled in a large observational study in Egypt.
Participants will receive the supplements daily for 18 months, with measures obtained every six months.
Measures to be assessed will include: retention in the study, compliance with study assignment, self-described symptoms, alanine aminotransferase (ALT) levels, serum collagen markers, abdominal ultrasound, viral load and clearance, and quality of life (SF36 survey).
It is hypothesized that silymarin will not lead to clearance of HCV infections but can prevent progression of liver disease in participants with chronic HCV hepatitis and, in some cases, reverse hepatic lesions that are already present, as well as improving the quality of life in individuals who use this dietary supplement.
This exploratory project is anticipated to result in successful initiation of larger and more definitive studies of the effect of milk thistle on HCV infection.
Evidence of beneficial effect of an inexpensive and benign herbal dietary supplement would have great impact on the large global population suffering from chronic HCV infection.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2000
Study Completion
June 1, 2002
Study Registration Dates
First Submitted
January 30, 2002
First Submitted That Met QC Criteria
January 30, 2002
First Posted (Estimate)
January 31, 2002
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Silymarin
Other Study ID Numbers
- R21AT000277-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C, Chronic
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
-
Ascletis Pharmaceuticals Co., Ltd.CompletedChronic Hepatitis cChina
-
Hospices Civils de LyonCompleted
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
Clinical Trials on Silymarin (milk thistle)
-
Vanderbilt UniversityWithdrawn
-
Madaus IncUniversity of Pennsylvania; Beth Israel Deaconess Medical Center; University... and other collaboratorsCompletedNon-alcoholic SteatohepatitisUnited States
-
University of Colorado, DenverSir Mortimer B. Davis - Jewish General HospitalCompleted
-
University of ChicagoWithdrawn
-
University of ChicagoCompletedTrichotillomania | Hair Pulling DisorderUnited States
-
University of Maryland, BaltimoreAlexandria University; MADAUS GmbH; The Egyptian Company for Blood Transfusion... and other collaboratorsTerminatedAcute Hepatitis C | Acute Hepatitis B | Acute Hepatitis A | Acute Hepatitis E | Acute EBV Hepatitis | Acute CMV HepatitisEgypt
-
University of ChicagoCompleted
-
National Institutes of Health Clinical Center (CC)CompletedHIV Infection | HealthyUnited States
-
National Center for Complementary and Integrative...National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedChronic Hepatitis CUnited States
-
Richard WhelanSt. Luke's-Roosevelt Hospital CenterTerminatedColon CancerUnited States