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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201578
Recruitment Status : Unknown
Verified January 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : April 27, 2006
Information provided by:
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease
Acute Hepatitis

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Study Type : Observational
Observational Model: Case-Control
Time Perspective: Other

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Abnormal liver function test
  • Hepatitis other than viral induced

Exclusion Criteria:

  • Under age 18 years old
  • Viral hepatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201578

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ting I Lai    23123456 ext 2831      
Sponsors and Collaborators
National Taiwan University Hospital
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Study Director: Jung D Wang National Taiwan University
Layout table for additonal information Identifier: NCT00201578    
Other Study ID Numbers: 9361701120
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 27, 2006
Last Verified: January 2005
Keywords provided by National Taiwan University Hospital:
Herbal Drugs
Alternative medicine
Additional relevant MeSH terms:
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Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections