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

Primary Purpose

Inflammatory Bowel Diseases, Crohn's Disease, Gastrointestinal Diseases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Mesalazine, Tripterygium glycosides

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Crohn's Disease, mesalazine, Tripterygium Glycosides, induction remission

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

General Surgery Institute, Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesalazine, Tripterygium glycosides

Arm Description

Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks

Outcomes

Primary Outcome Measures

Therapeutic effect measured by Crohn's Disease Activity Index (CDAI)

Secondary Outcome Measures

The Side effects of Tripterygium wilfordii (TW)

The change of Crohn's Disease Activity Index (CDAI )

The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)

The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)

Full Information

NCT ID

NCT02044952

First Posted

January 19, 2014

Last Updated

January 22, 2014

Sponsor

Zhu Weiming

1. Study Identification

Unique Protocol Identification Number

NCT02044952

Brief Title

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

Official Title

Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhu Weiming

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases, Crohn's Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases

Keywords

Crohn's Disease, mesalazine, Tripterygium Glycosides, induction remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesalazine, Tripterygium glycosides

Arm Type

Experimental

Arm Description

Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Mesalazine, Tripterygium glycosides

Other Intervention Name(s)

Triptolide, Lei gong teng, Thunder god vine

Intervention Description

tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral

Primary Outcome Measure Information:

Title

Therapeutic effect measured by Crohn's Disease Activity Index (CDAI)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The Side effects of Tripterygium wilfordii (TW)

Time Frame

12 weeks

Title

The change of Crohn's Disease Activity Index (CDAI )

Time Frame

12Weeks

Title

The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)

Time Frame

12 Weeks

Title

The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wei ming zhu, PhD,MD

Phone

+86-25-80860137

dr_zhuweiming@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wei ming zhu, PhD,MD

Organizational Affiliation

General Surgery Institute, Jinling Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Surgery Institute, Jinling Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

wei ming zhu, PhD,MD

Phone

+86-25-80860137

dr_zhuweiming@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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