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

NCT ID: NCT02044952

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mesalazine, Tripterygium glycosides

Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks

Group Type: EXPERIMENTAL

Mesalazine, Tripterygium glycosides

Intervention Type: DRUG

tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral

Interventions

Mesalazine, Tripterygium glycosides

tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral

Intervention Type: DRUG

Other Intervention Names

Triptolide; Lei gong teng; Thunder god vine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Weiming

OTHER

Sponsor Role: lead

Responsible Party

Zhu Weiming

General Surgery Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

wei ming zhu, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

General Surgery Institute, Jinling Hospital

Locations

General Surgery Institute, Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei ming zhu, PhD,MD

Role: CONTACT

dr_zhuweiming@126.com

+86-25-80860137

Facility Contacts

wei ming zhu, PhD,MD

Role: primary

dr_zhuweiming@126.com

+86-25-80860137

Other Identifiers

CDTW-1

Identifier Type: -

Identifier Source: org_study_id