Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

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 between 150 to 270 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 Criteria:

• Bacterial, viral or other microbial infection(including HIV).

• Orally administered corticosteroids within 3 weeks before enrollment, Inhaled ordermatologic preparations for the treatment of other diseases are acceptable.

• Used of infliximab or immunosuppressant within 2 months before enrollment.

• Previous use of prescription doses of NSAIDs without efficacy.

• Treatment with narcotic pain medications(Anti-diarrheal agents such as loperamide anddiphenoxylate 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 3 months.