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Clinical Trials/NCT01696838
NCT01696838CompletedNot Applicable

Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)

Shanghai Institute of Acupuncture, Moxibustion and Meridian1 site in 1 country61 target enrollmentStarted: September 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
61
Locations
1
Primary Endpoint
CDAI

Study Overview

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.

Detailed Description

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.

Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for 12 weeks, Compare the different brain activation by the different therapies and observe the correlation between brain activation and efficacy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

CDAI

Time Frame: 1 year

Crohn's Disease Activity Index

Secondary Outcomes

  • IBDQ(1 year)
  • fMRI(1 year)
  • Inflammatory factors(1 and a half years)
  • Neurotransmitter(1 and a half years)

Investigators

Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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