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

Tracking Information
First Submitted Date	September 12, 2005
First Posted Date	September 20, 2005
Last Update Posted Date	April 27, 2006
Study Start Date	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00201578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Case Control Study of Non Viral Hepatitis Relating to Herbal Drug Use in the Emergency Department
Official Title	Not Provided
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Cross-Sectional; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Acute Hepatitis
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Enrollment	Not Provided
Original Enrollment	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: Abnormal liver function test; Hepatitis other than viral induced Exclusion Criteria: Under age 18 years old; Viral hepatitis
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Not Provided
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Taiwan
Removed Location Countries
Administrative Information
NCT Number	NCT00201578
Other Study ID Numbers	9361701120
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	National Taiwan University Hospital
Collaborators	Not Provided
Investigators	Study Director: Jung D Wang National Taiwan University
PRS Account	National Taiwan University Hospital
Verification Date	January 2005