Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
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|ClinicalTrials.gov Identifier: NCT02044952|
Recruitment Status : Unknown
Verified January 2014 by Zhu Weiming, Jinling Hospital, China.
Recruitment status was: Recruiting
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Crohn's Disease Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases||Drug: Mesalazine, Tripterygium glycosides||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Mesalazine, Tripterygium glycosides
Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks
Drug: Mesalazine, Tripterygium glycosides
tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral
- Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) [ Time Frame: 12 weeks ]
- The Side effects of Tripterygium wilfordii (TW) [ Time Frame: 12 weeks ]
- The change of Crohn's Disease Activity Index (CDAI ) [ Time Frame: 12Weeks ]
- The change of Simple Endoscopic Score for Crohn's Disease(SES-CD) [ Time Frame: 12 Weeks ]
- The change of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044952
|Contact: wei ming zhu, PhD,MDfirstname.lastname@example.org|
|General Surgery Institute, Jinling Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: wei ming zhu, PhD,MD +86-25-80860137 email@example.com|
|Principal Investigator:||wei ming zhu, PhD,MD||General Surgery Institute, Jinling Hospital|