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

September 2, 2016 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Institute of Acupuncture-Moxibustion and Merdian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • acupuncture
Other: moxibustion
patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
Other Names:
  • 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 Names:
  • acupuncture
Other: moxibustion
patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
Other Names:
  • herbs-partitioned moxibustion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDAI
Time Frame: 1 year
Crohn's Disease Activity Index
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI
Time Frame: 1 year
Brain activiation tested by BOLD fMRI
1 year
IBDQ
Time Frame: 1 year
Inflammatory Bowel Disease Questionnaire
1 year
Inflammatory factors
Time Frame: 1 and a half years
Intestinal mucosa of IL-6,IL-17,IL-23,etc
1 and a half years
Neurotransmitter
Time Frame: 1 and a half years
5-HT,DA,etc
1 and a half years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Investigators

  • Study Chair: Wu Huangan, PhD, Shanghai Institute of Acupuncture, Moxibustion and Meridian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 1, 2012

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHACU-201201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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