Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

Not Applicable

• Conditions: Crohn's Disease
• Interventions: Drug: enteral nutrition; Drug: Tripterygium glycosides

• Registration Number: NCT01820247
• Lead Sponsor: Zhu Weiming

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.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2013-03
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-27
• Last Update Submitted: 2013-03-27
• Study First Posted: 2013-03-28
• Last Update Posted: 2013-03-28
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enteral nutrition	enteral nutrition	The patients receive treatment of enteral nutrition only.
tripterygium glycosides	Tripterygium glycosides	The patients receive treatment of tripterygium glycosides only.
tripterygium glycosides and enteral nutrition	enteral nutrition	The patients receive treatment of tripterygium glycosides and enteral nutrition.
tripterygium glycosides and enteral nutrition	Tripterygium glycosides	The patients receive treatment of tripterygium glycosides and enteral nutrition.

Primary Outcome Measures

Name	Time	Method
Therapeutic effect measured by CDAI and enteroscope	12 weeks

Trial Locations

Locations (1)

General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China; 🇨🇳 Nanjing, Jiangsu, China