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Completed

NCT Number: NCT01696838

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electroacupuncture

Other

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

moxibustion

Other

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

Other names: herbs-partitioned moxibustion

Primary outcomes

  1. CDAI

    Time frame: 1 year

    Crohn's Disease Activity Index

Secondary outcomes

  1. fMRI

    Time frame: 1 year

    Brain activiation tested by BOLD fMRI

  2. IBDQ

    Time frame: 1 year

    Inflammatory Bowel Disease Questionnaire

  3. Inflammatory factors

    Time frame: 1 and a half years

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

  4. Neurotransmitter

    Time frame: 1 and a half years

    5-HT,DA,etc

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2012
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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