Crohn's Disease Clinical Trial
Official title:
Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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