Status:
UNKNOWN
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
Lead Sponsor:
Zhu Weiming
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic eff...
Detailed Description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreas...
Eligibility Criteria
Inclusion
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Subjects should have a CDAI score ≥ 150 at week 0
- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
- Willing to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Bacterial,viral or other microbial infection(including HIV)
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs
- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- History of abnormal liver function tests, including AST or ALT \>1.5 times upper limit of normal, alkaline phosphatase \>2 times upper limit of normal, total bilirubin \>2.5 mg/dL at screening (or within the previous 6 months, if known)
- History of malignancy
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 6 months
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01820247
Start Date
December 1 2012
End Date
September 1 2013
Last Update
March 28 2013
Active Locations (1)
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1
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu, China, 210000