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CompletedNCT01696838Updated Sep 5, 2016

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

An interventional study of electroacupuncture and moxibustion in Crohn's Disease and CAM, sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-05.

Sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn's Disease
  • CAM

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Keywords

  • Crohn's disease
  • acupuncture
  • moxibustion
  • fMRI
  • Gut
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 61 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    EA group

    Electroacupuncture group

    Other: electroacupuncture · Other: moxibustion

  • Experimental
    MOX group

    Herbs-partitioned moxibustion group

    Other: electroacupuncture · Other: moxibustion

Interventions

  • Otherelectroacupuncture

    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.

    Also known as: acupuncture

  • Othermoxibustion

    patients receive herbs-partitioned moxibustion for 2 cones,3 times a week for 12 weeks.

    Also known as: herbs-partitioned moxibustion

06

What researchers measure

Primary outcomes

  1. CDAI

    Crohn's Disease Activity Index

    Time frame: 1 year

Secondary outcomes

  1. fMRI

    Brain activiation tested by BOLD fMRI

    Time frame: 1 year

  2. IBDQ

    Inflammatory Bowel Disease Questionnaire

    Time frame: 1 year

  3. Inflammatory factors

    Intestinal mucosa of IL-6,IL-17,IL-23,etc

    Time frame: 1 and a half years

  4. Neurotransmitter

    5-HT,DA,etc

    Time frame: 1 and a half years

07

Study locations

1 site
  • Shanghai Institute of Acupuncture-Moxibustion and Merdian
    Shanghai, Shanghai 200030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01696838
Lead sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Responsible party
Sponsor
First posted
Oct 1, 2012
Start date
Sep 2012
Primary completion
Apr 2014
Completion
Nov 2014
Last update
Sep 5, 2016

Study contacts

Wu Huangan, PhD
study chair · Shanghai Institute of Acupuncture, Moxibustion and Meridian

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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