Crohn's Disease Clinical Trial
Official title:
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | November 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Institute of Acupuncture-Moxibustion and Merdian | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Institute of Acupuncture, Moxibustion and Meridian |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CDAI | Crohn's Disease Activity Index | 1 year | No |
Secondary | fMRI | Brain activiation tested by BOLD fMRI | 1 year | No |
Secondary | IBDQ | Inflammatory Bowel Disease Questionnaire | 1 year | No |
Secondary | Inflammatory factors | Intestinal mucosa of IL-6,IL-17,IL-23,etc | 1 and a half years | Yes |
Secondary | Neurotransmitter | 5-HT,DA,etc | 1 and a half years | Yes |
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