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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT02044952
First received: January 19, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Inflammatory Bowel Diseases
Crohn's Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Drug: Mesalazine, Tripterygium glycosides
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Side effects of Tripterygium wilfordii (TW) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The change of Crohn's Disease Activity Index (CDAI ) [ Time Frame: 12Weeks ] [ Designated as safety issue: No ]
  • The change of Simple Endoscopic Score for Crohn's Disease(SES-CD) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The change of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044952

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

Locations
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
Principal Investigator: wei ming zhu, PhD,MD General Surgery Institute, Jinling Hospital
  More Information

No publications provided

Responsible Party: Zhu Weiming, General Surgery Institute, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02044952     History of Changes
Other Study ID Numbers: CDTW-1
Study First Received: January 19, 2014
Last Updated: January 22, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Jinling Hospital, China:
Crohn's Disease
mesalazine
Tripterygium Glycosides
induction remission

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Mesalamine
Cardiac Glycosides
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014