Trials / Unknown
UnknownNCT02044952
Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Zhu Weiming · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mesalazine, Tripterygium glycosides | tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2016-05-01
- Completion
- 2016-07-01
- First posted
- 2014-01-24
- Last updated
- 2014-01-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02044952. Inclusion in this directory is not an endorsement.