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

Last updated: March 27, 2013
Sponsor: Zhu Weiming
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Colic

Bowel Dysfunction

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT01820247
CD-IT1
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atthe 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 ofenrollment

  • Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion

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 orchronic/frequent use of NSAIDs

  • Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamideand diphenoxylate are permitted)

  • History of pancreatitis, except for subjects with a known but removed cause(such asgallstone pancreatitis)

  • History of abnormal liver function tests, including AST or ALT >1.5 times upper limitof normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5mg/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 beduring the study period.

  • Participation in other clinical trial within the past 6 months

Study Design

Total Participants: 100
Study Start date:
December 01, 2012
Estimated Completion Date:
September 30, 2013

Study 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.

Connect with a study center

  • General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

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