NCT01696838

Brief Summary

The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2012

Enrollment Period

1.6 years

First QC Date

September 25, 2012

Last Update Submit

September 2, 2016

Conditions

Crohn's DiseaseCAM

Keywords

Crohn's diseaseacupuncturemoxibustionfMRIGut

Outcome Measures

Primary Outcomes (1)

  • CDAI

    Crohn's Disease Activity Index

    1 year

Secondary Outcomes (4)

  • fMRI

    1 year

  • IBDQ

    1 year

  • Inflammatory factors

    1 and a half years

  • Neurotransmitter

    1 and a half years

Study Arms (2)

EA group

EXPERIMENTAL

Electroacupuncture group

Other: electroacupunctureOther: moxibustion

MOX group

EXPERIMENTAL

Herbs-partitioned moxibustion group

Other: electroacupunctureOther: moxibustion

Interventions

electroacupunctureOTHER

Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.

Also known as: acupuncture
EA groupMOX group
moxibustionOTHER

patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.

Also known as: herbs-partitioned moxibustion
EA groupMOX group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-50 years;
  • right-handed;
  • clinical remission (Crohn's Disease Activity Index \[CDAI\]≤150) for at least 6 months prior to the study;
  • C-reactive protein(CRP)\<10 mg/l;
  • erythrocyte sedimentation rate (ESR) \<20 mm/h
  • signing awritten informed consent form.

You may not qualify if:

  • use of corticosteroids and psychotropic medications in the previous 30 days;
  • current or prior history of neurological or psychiatric disease based
  • on physicians' examination and questionnaires;
  • current or prior history of neurosurgery, head injury, cerebrovascular
  • insult, or brain trauma involving loss of consciousness;
  • learning disability;
  • claustrophobia;
  • presence of metallic implants in the body;
  • being pregnant or during lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

ElectroacupunctureAcupuncture TherapyMoxibustion

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Wu Huangan, PhD

    Shanghai Institute of Acupuncture, Moxibustion and Meridian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 1, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

September 5, 2016

Record last verified: 2012-09

Locations

CN(1)