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