Acute Hepatitis Clinical Trial
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.
n/a
Observational Model: Case Control, Time Perspective: Cross-Sectional
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