Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201578
Status:
UNKNOWN
Last Update Posted:
2006-04-27
First Post:
2005-09-12
Brief Title:
Case Control Study of Non Viral Hepatitis Relating to Herbal Drug Use in the Emergency Department
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None