The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who received mesalazine.
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 immune-modulatory 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 is efficient for induction of remission in patients with mild to moderate 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 and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received mesalazine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral
General Surgery Institute, Jinling Hospital
Nanjing, Jiangsu, China
RECRUITINGTherapeutic effect measured by Crohn's Disease Activity Index (CDAI)
Time frame: 12 weeks
The Side effects of Tripterygium wilfordii (TW)
Time frame: 12 weeks
The change of Crohn's Disease Activity Index (CDAI )
Time frame: 12Weeks
The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)
Time frame: 12 Weeks
The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 12 Weeks
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