Case Control Study of Non Viral Hepatitis Relating to Herbal Drug Use in the Emergency Department

April 27, 2006 updated by: National Taiwan University Hospital

The use of traditional Chinese herbal medicine and various forms of alternative medicine to maintain health among the Chinese ethnic group has had a long history and has been deeply rooted in the Chinese way of living for centuries. It has been a general belief that these therapies consist of "natural" substances and are less toxic than their western synthetic drug counterparts. However, recent reports of side effects of systemic traditional Chinese medicine, including hypersensitivity, hepatotoxicity, neurotoxicity, cardiovascular toxicity, renal failure, and contact dermatitis, have been increasing.

Since there is a high prevalence in the usage of traditional Chinese herbal medicine in Taiwan, this study examines the frequency of patients using herbal medicine whose initial diagnosis in the emergency department (ED) is acute non viral hepatitis. We, the researchers at National Taiwan University Hospital, then correlate if the cause of hepatitis is related to the use of these herbal drugs by taking a detailed history of medication or herbs used and by verifying the contents by chemical analysis of the "medications" used. To our knowledge, this is the first study in examining the relationship between non viral hepatitis and the use of herbal drugs prior to arriving at the ED. We expect to prove adverse effects of these substances, especially hepatitis, is the cause for requiring emergency care.

Our study design is a prospective, density sampling case control study in which one hundred patients with non viral hepatitis will be recruited as our case. We use a questionnaire designed by the investigator in the survey of demographic background, education, and income status of the cases, as well as the frequency of use of the drug, total dosage used, where the drug was purchased, what the drug is used for, and whether they know of any adverse effect that the drug might have. If they had taken the drug within three months prior to this emergency visit, then they are asked to bring the drug in for examination. Examination of the drug includes the use of high performance liquid chromatography (HPLC) and if necessary, inductively coupled plasma mass spectrometry (ICP mass). In contrast, our control group consists of subjects that are admitted to the ED due to trauma or fracture. For each case, they are matched with two subjects in the control group in both gender and age. They should also arrive within two days after the arrival of the case. All cases and controls are screened for viral hepatitis and serology must be negative before entering the study. The questionnaire is given to both groups. If more than one control is eligible to enter the study, then the control is chosen by a random draw in a hat. After this use of density sampling, we collect the data and logistic regression is used for analysis.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Ting I Lai
          • Phone Number: 2831 23123456

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Abnormal liver function test
  • Hepatitis other than viral induced

Exclusion Criteria:

  • Under age 18 years old
  • Viral hepatitis

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Jung D Wang, National Taiwan University

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 Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 27, 2006

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9361701120

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.

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