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

Primary Purpose

Crohn's Disease, CAM

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
moxibustion
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, acupuncture, moxibustion, fMRI, Gut

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Institute of Acupuncture-Moxibustion and Merdian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EA group

MOX group

Arm Description

Electroacupuncture group

Herbs-partitioned moxibustion group

Outcomes

Primary Outcome Measures

CDAI
Crohn's Disease Activity Index

Secondary Outcome Measures

fMRI
Brain activiation tested by BOLD fMRI
IBDQ
Inflammatory Bowel Disease Questionnaire
Inflammatory factors
Intestinal mucosa of IL-6,IL-17,IL-23,etc
Neurotransmitter
5-HT,DA,etc

Full Information

First Posted
September 25, 2012
Last Updated
September 2, 2016
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT01696838
Brief Title
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI
Official Title
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, CAM
Keywords
Crohn's disease, acupuncture, moxibustion, fMRI, Gut

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA group
Arm Type
Experimental
Arm Description
Electroacupuncture group
Arm Title
MOX group
Arm Type
Experimental
Arm Description
Herbs-partitioned moxibustion group
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Other Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
moxibustion
Other Intervention Name(s)
herbs-partitioned moxibustion
Intervention Description
patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
Primary Outcome Measure Information:
Title
CDAI
Description
Crohn's Disease Activity Index
Time Frame
1 year
Secondary Outcome Measure Information:
Title
fMRI
Description
Brain activiation tested by BOLD fMRI
Time Frame
1 year
Title
IBDQ
Description
Inflammatory Bowel Disease Questionnaire
Time Frame
1 year
Title
Inflammatory factors
Description
Intestinal mucosa of IL-6,IL-17,IL-23,etc
Time Frame
1 and a half years
Title
Neurotransmitter
Description
5-HT,DA,etc
Time Frame
1 and a half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Huangan, PhD
Organizational Affiliation
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Institute of Acupuncture-Moxibustion and Merdian
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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