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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Triptolide
  • Lei gong teng
  • Thunder god vine


Outcome Measures
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Primary Outcome Measures :
  1. Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The Side effects of Tripterygium wilfordii (TW) [ Time Frame: 12 weeks ]
  2. The change of Crohn's Disease Activity Index (CDAI ) [ Time Frame: 12Weeks ]
  3. The change of Simple Endoscopic Score for Crohn's Disease(SES-CD) [ Time Frame: 12 Weeks ]
  4. The change of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 12 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: wei ming zhu, PhD,MD +86-25-80860137 dr_zhuweiming@126.com

Locations
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China, Jiangsu
General Surgery Institute, Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: wei ming zhu, PhD,MD    +86-25-80860137    dr_zhuweiming@126.com   
Sponsors and Collaborators
Zhu Weiming
Investigators
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Principal Investigator: wei ming zhu, PhD,MD General Surgery Institute, Jinling Hospital
More Information
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Responsible Party: Zhu Weiming, General Surgery Institute, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02044952    
Other Study ID Numbers: CDTW-1
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014
Keywords provided by Zhu Weiming, Jinling Hospital, China:
Crohn's Disease
mesalazine
Tripterygium Glycosides
induction remission
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Mesalamine
Triptolide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action
Antispermatogenic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents