NCT00412763

Brief Summary

The overall objective of this project is to assess whether Silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. We will specifically compare responses in acute hepatitis patients treated with Silymarin to those given a control preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled trial.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

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

July 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

First QC Date

December 15, 2006

Last Update Submit

April 21, 2021

Conditions

Hepatitis

Keywords

Acute hepatitisAcute viral hepatitisAcute nonviral hepatitisSilymarinMilk Thistle

Outcome Measures

Primary Outcomes (1)

  • Primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8.

Secondary Outcomes (1)

  • Side-effects and adverse events were ascertained by self-report on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8. .

Interventions

Silymarin (Silybum marianum)DRUG

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
  • Recent (\<1 month) history of illness.
  • Elevation of ALT \> 2.5 normal.
  • At least 13 years old.

You may not qualify if:

  • History suggestive of severe drug-induced acute hepatitis.
  • Children 12 years and younger.
  • Pregnant or breastfeeding women
  • Suspected hypersensitivity to Silymarin or vitamin preparations.
  • Evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
  • Patients who are critically ill, with multisystem failure or cancer.
  • Substance abuse such as IV drugs.
  • Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis

Interventions

Silymarinmilk-thistle extract

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • George T Strickland, MD, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

July 1, 2003

Study Completion

October 1, 2005

Last Updated

April 23, 2021

Record last verified: 2021-04