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

Crohn's Disease Clinical Trial

Official title:

Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02044952
• Other study ID #: CDTW-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 19, 2014
• Last updated: January 22, 2014
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: January 2014
• Source: Jinling Hospital, China
• Contact: wei ming zhu, PhD,MD
• Phone: +86-25-80860137
• Email: dr_zhuweiming[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	General Surgery Institute, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Weiming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effect measured by Crohn's Disease Activity Index (CDAI)		12 weeks	No
Secondary	The Side effects of Tripterygium wilfordii (TW)		12 weeks	Yes
Secondary	The change of Crohn's Disease Activity Index (CDAI )		12Weeks	No
Secondary	The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)		12 Weeks	No
Secondary	The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)		12 Weeks	No