NCT01292161

Brief Summary

The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
Last Updated

February 9, 2011

Status Verified

September 1, 2006

Enrollment Period

6 months

First QC Date

February 8, 2011

Last Update Submit

February 8, 2011

Conditions

Hepatitis C

Keywords

Hepatitis CSilymarinQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

    at six months after admission

Secondary Outcomes (1)

  • HCV-RNA

    at six months after admission

Study Arms (1)

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.

Drug: Silymarin

Interventions

SilymarinDRUG

Tab 210 mg, 630 mg, daily, six months.

Silymarin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The pregnant patients patients with side effect which confirmed with rechallenge test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • hamid kalantari, A.Professor

    Associate Professor,Gasteroentrology department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

March 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

February 9, 2011

Record last verified: 2006-09

Locations

IR(1)