NCT01820247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

March 25, 2013

Last Update Submit

March 27, 2013

Conditions

Crohn's Disease

Keywords

Crohn's Diseaseenteral nutritionTripterygium Glycosidesinduction remission

Outcome Measures

Primary Outcomes (1)

  • Therapeutic effect measured by CDAI and enteroscope

    12 weeks

Study Arms (3)

enteral nutrition

EXPERIMENTAL

The patients receive treatment of enteral nutrition only.

Drug: enteral nutrition

tripterygium glycosides

EXPERIMENTAL

The patients receive treatment of tripterygium glycosides only.

Drug: Tripterygium glycosides

tripterygium glycosides and enteral nutrition

EXPERIMENTAL

The patients receive treatment of tripterygium glycosides and enteral nutrition.

Drug: enteral nutritionDrug: Tripterygium glycosides

Interventions

enteral nutritionDRUG
enteral nutritiontripterygium glycosides and enteral nutrition
Tripterygium glycosidesDRUG
tripterygium glycosidestripterygium glycosides and enteral nutrition

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice director of General surgery institute

Study Record Dates

First Submitted

March 25, 2013

First Posted

March 28, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

CN(1)