Hepatitis CPhase 2NCT01292161
Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C
A Phase 2 study testing Silymarin in people with Hepatitis C, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Silymarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIran
- Study dates
- Mar 2006to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting.
Who cannot join
- The pregnant patients patients with side effect which confirmed with rechallenge test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Silymarin for Improving Hepatitis C
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.
Read the detailed description
Silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.
- Conditions
- Hepatitis C
- Being tested
- Silymarin
- Keywords
- Hepatitis C, Silymarin, Quality of life
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
Tab 210 mg, 630 mg, daily, six months.
| Study group | Role | What they receive |
|---|---|---|
| Silymarin | Other | Silymarin drived from Silybum marianum (milk thistle), a flowering member of the daisy family, may benefit liver function in people infected with the hepatitis C virus. Receives: Drug: Silymarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum aminotransferases (ALT, AST)
The investigators measured serum amino transferases by commercial AST kit,. ALT kits(Bayer Diagnostics,. Tarrytown, NY, USA) at six months after silymarin admission
Measured: at six months after admission
Secondary outcomes (1)
HCV-RNA
The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission
Measured: at six months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMar 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamid kalantari, A.Professor, Principal investigator, Associate Professor,Gasteroentrology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292161
- Sponsor's protocol ID
- ASD-1213-15
- Status last verified
- Sep 2006
- First submitted
- 8 Feb 2011
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Silymarin for Improving Hepatitis C
- ClinicalTrials.gov ID
- NCT01292161
- Acronym / sponsor ID
- ASD-1213-15
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Silymarin, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.
Detailed description
Silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silymarin | Other | Drug: SilymarinSilymarin drived from Silybum marianum (milk thistle), a flowering member of the daisy family, may benefit liver function in people infected with the hepatitis C virus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting.
Key exclusion criteria (1 listed)
- The pregnant patients patients with side effect which confirmed with rechallenge test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilymarinTab 210 mg, 630 mg, daily, six months. | Drug | Silymarin |
Primary outcome
Serum aminotransferases (ALT, AST)
Time frame: at six months after admission
The investigators measured serum amino transferases by commercial AST kit,. ALT kits(Bayer Diagnostics,. Tarrytown, NY, USA) at six months after silymarin admission
1 secondary outcome
HCV-RNA
Time frame: at six months after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- Isfahan university of medical sciencesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hamid kalantari, A.Professor principal investigator
Associate Professor,Gasteroentrology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silymarin in people with Hepatitis C, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum aminotransferases (ALT, AST) (time frame: at six months after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.