NCT02044952

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.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

January 19, 2014

Last Update Submit

January 22, 2014

Conditions

Inflammatory Bowel DiseasesCrohn's DiseaseGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Keywords

Crohn's DiseasemesalazineTripterygium Glycosidesinduction remission

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (4)

  • The Side effects of Tripterygium wilfordii (TW)

    12 weeks

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

    12Weeks

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

    12 Weeks

  • The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)

    12 Weeks

Study Arms (1)

Mesalazine, Tripterygium glycosides

EXPERIMENTAL

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

Drug: Mesalazine, Tripterygium glycosides

Interventions

Mesalazine, Tripterygium glycosidesDRUG

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

Also known as: Triptolide, Lei gong teng, Thunder god vine
Mesalazine, Tripterygium glycosides

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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Institute, Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Interventions

Mesalaminetriptolidelei gong teng

Condition Hierarchy (Ancestors)

Gastroenteritis

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • wei ming zhu, PhD,MD

    General Surgery Institute, Jinling Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wei ming zhu, PhD,MD

CONTACT

+86-25-80860137dr_zhuweiming@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Surgery Institute

Study Record Dates

First Submitted

January 19, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

CN(1)