Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalazine, Tripterygium glycosides | Experimental | Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalazine, Tripterygium glycosides | Drug | tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Side effects of Tripterygium wilfordii (TW) | 12 weeks | |
| The change of Crohn's Disease Activity Index (CDAI ) | 12Weeks | |
| The change of Simple Endoscopic Score for Crohn's Disease(SES-CD) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei ming zhu, PhD,MD | Contact | +86-25-80860137 | dr_zhuweiming@126.com |
| Name | Affiliation | Role |
|---|---|---|
| wei ming zhu, PhD,MD | General Surgery Institute, Jinling Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery Institute, Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Weeks |
| The change of the Inflammatory Bowel Disease Questionnaire (IBDQ) | 12 Weeks |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
Not provided
Not provided
| ID | Term |
|---|---|
| D019804 | Mesalamine |
| C001899 | triptolide |
| C041579 | lei gong teng |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
Not provided
Not provided