Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier:
NCT01696838
First received: September 25, 2012
Last updated: October 28, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Crohn's Disease
CAM
Other: electroacupuncture
Other: moxibustion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)

Resource links provided by NLM:


Further study details as provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:

Primary Outcome Measures:
  • CDAI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Crohn's Disease Activity Index


Secondary Outcome Measures:
  • fMRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Brain activiation tested by BOLD fMRI

  • IBDQ [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire

  • Inflammatory factors [ Time Frame: 1 and a half years ] [ Designated as safety issue: Yes ]
    Intestinal mucosa of IL-6,IL-17,IL-23,etc

  • Neurotransmitter [ Time Frame: 1 and a half years ] [ Designated as safety issue: Yes ]
    5-HT,DA,etc


Estimated Enrollment: 72
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EA group
Electroacupuncture group
Other: electroacupuncture
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.
Other Name: acupuncture
Other: moxibustion
patients receive herbs-partitioned moxibustion for 2 cones,3 times a week for 12 weeks.
Other Name: herbs-partitioned moxibustion
Experimental: MOX group
Herbs-partitioned moxibustion group
Other: electroacupuncture
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.
Other Name: acupuncture
Other: moxibustion
patients receive herbs-partitioned moxibustion for 2 cones,3 times a week for 12 weeks.
Other Name: herbs-partitioned moxibustion

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696838

Locations
China, Shanghai
Shanghai Institute of Acupuncture-Moxibustion and Merdian
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
Study Chair: Wu Huangan, PhD Shanghai Institute of Acupuncture, Moxibustion and Meridian
  More Information

No publications provided

Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT01696838     History of Changes
Other Study ID Numbers: SHACU-201201
Study First Received: September 25, 2012
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration
China: Ethics Committee

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
Crohn's disease
acupuncture
moxibustion
fMRI
Gut

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 23, 2014