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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02044952
• Date of registration: 19/01/2014
• Prospective Registration: No
• Primary sponsor: Zhu Weiming
• Public title: Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
• Scientific title: Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
• Date of first enrolment: January 2014
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02044952
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: wei ming zhu, PhD,MD

• Name: wei ming zhu, PhD,MD

• Name: wei ming zhu, PhD,MD
• Affiliation: General Surgery Institute, Jinling Hospital

Key inclusion & exclusion criteria

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
at the 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 of
enrollment.

- 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 or
dermatologic 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 and
diphenoxylate are permitted).

- History of pancreatitis, except for subjects with a known but removed cause(such as
gallstone pancreatitis).

- 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.

- Women who are pregnant or lactating at the time of enrollment, or who intend to be
during the study period.

- Participation in other clinical trial within the past 3 months.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Digestive System Diseases

Crohn's Disease

Gastrointestinal Diseases

Intestinal Diseases

Intervention(s)

Drug: Mesalazine, Tripterygium glycosides

Primary Outcome(s)

Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) [Time Frame: 12 weeks]

Secondary Outcome(s)

The change of Simple Endoscopic Score for Crohn's Disease(SES-CD) [Time Frame: 12 Weeks]

The change of Crohn's Disease Activity Index (CDAI ) [Time Frame: 12Weeks]

The Side effects of Tripterygium wilfordii (TW) [Time Frame: 12 weeks]

The change of the Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: 12 Weeks]

Secondary ID(s)

CDTW-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors