Suspended

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

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What is being tested

enteral nutrition

+ Tripterygium glycosides

+ enteral nutrition

Drug
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 75 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorZhu Weiming
Study Contactwei ming zhu, PhD,MDMore contacts
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01820247
Principal SponsorZhu Weiming
Study Contactwei ming zhu, PhD,MDMore contacts
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel DiseasesCrohn Disease

Criteria

6 inclusion criteria required to participate
Able to swallow tablets
Are capable of providing written informed consent and obtained at the time of enrollment
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
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9 exclusion criteria prevent from participating
Bacterial,viral or other microbial infection(including HIV)
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
History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The patients receive treatment of enteral nutrition only.

Group II

Experimental
The patients receive treatment of tripterygium glycosides only.

Group III

Experimental
The patients receive treatment of tripterygium glycosides and enteral nutrition.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Nanjing, ChinaOpen General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China in Google Maps
SuspendedOne Study Center