Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
enteral nutrition
Tripterygium glycosides
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, enteral nutrition, Tripterygium Glycosides, induction remission
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
enteral nutrition
tripterygium glycosides
tripterygium glycosides and enteral nutrition
Arm Description
The patients receive treatment of enteral nutrition only.
The patients receive treatment of tripterygium glycosides only.
The patients receive treatment of tripterygium glycosides and enteral nutrition.
Outcomes
Primary Outcome Measures
Therapeutic effect measured by CDAI and enteroscope
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01820247
Brief Title
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
Official Title
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Weiming
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 effect with patients who only received Tripterygium Glycosides or enteral nutrition.
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 decreased quality of life and an increased risk of chronic disability and unemployment.
Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
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 effect with patients who only received Tripterygium Glycosides or enteral nutrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, enteral nutrition, Tripterygium Glycosides, induction remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
enteral nutrition
Arm Type
Experimental
Arm Description
The patients receive treatment of enteral nutrition only.
Arm Title
tripterygium glycosides
Arm Type
Experimental
Arm Description
The patients receive treatment of tripterygium glycosides only.
Arm Title
tripterygium glycosides and enteral nutrition
Arm Type
Experimental
Arm Description
The patients receive treatment of tripterygium glycosides and enteral nutrition.
Intervention Type
Drug
Intervention Name(s)
enteral nutrition
Intervention Type
Drug
Intervention Name(s)
Tripterygium glycosides
Primary Outcome Measure Information:
Title
Therapeutic effect measured by CDAI and enteroscope
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei ming zhu, PhD,MD
Phone
+86-25-80860137
Email
dr_zhuweiming@126.com
First Name & Middle Initial & Last Name & Degree
wei ming zhu, PhD,MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
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