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

March 27, 2013 updated by: Zhu Weiming
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
        • Contact:
        • Principal Investigator:
          • wei ming zhu, PhD,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: enteral nutrition
The patients receive treatment of enteral nutrition only.
Drug: enteral nutrition
Experimental: tripterygium glycosides
The patients receive treatment of tripterygium glycosides only.
Drug: Tripterygium glycosides
Experimental: tripterygium glycosides and enteral nutrition
The patients receive treatment of tripterygium glycosides and enteral nutrition.
Drug: enteral nutrition
Drug: Tripterygium glycosides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic effect measured by CDAI and enteroscope
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhu Weiming

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-IT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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