Back to results

Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

Primary Purpose

Crohn's Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

enteral nutrition

Tripterygium glycosides

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, enteral nutrition, 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 ≥ 150 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)
Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs
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 6 months

Sites / Locations

General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

enteral nutrition

tripterygium glycosides

tripterygium glycosides and enteral nutrition

Arm Description

The patients receive treatment of enteral nutrition only.

The patients receive treatment of tripterygium glycosides only.

The patients receive treatment of tripterygium glycosides and enteral nutrition.

Outcomes

Primary Outcome Measures

Therapeutic effect measured by CDAI and enteroscope

Secondary Outcome Measures

Full Information

NCT ID

NCT01820247

First Posted

March 25, 2013

Last Updated

March 27, 2013

Sponsor

Zhu Weiming

1. Study Identification

Unique Protocol Identification Number

NCT01820247

Brief Title

Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

Official Title

Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhu Weiming

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.

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 immunomodulatory 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, or combined with enteral nutrition, is efficient for induction of remission in patients with 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 of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.

6. Conditions and Keywords

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

Crohn's Disease

Keywords

Crohn's Disease, enteral nutrition, Tripterygium Glycosides, induction remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

enteral nutrition

Arm Type

Experimental

Arm Description

The patients receive treatment of enteral nutrition only.

Arm Title

tripterygium glycosides

Arm Type

Experimental

Arm Description

The patients receive treatment of tripterygium glycosides only.

Arm Title

tripterygium glycosides and enteral nutrition

Arm Type

Experimental

Arm Description

The patients receive treatment of tripterygium glycosides and enteral nutrition.

Intervention Type

Drug

Intervention Name(s)

enteral nutrition

Intervention Type

Drug

Intervention Name(s)

Tripterygium glycosides

Primary Outcome Measure Information:

Title

Therapeutic effect measured by CDAI and enteroscope

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 ≥ 150 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) Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable. Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs 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 6 months

Facility Information:

Facility Name

General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

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

First Name & Middle Initial & Last Name & Degree

wei ming zhu, PhD,MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

We'll reach out to this number within 24 hrs