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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01696838
Other study ID # SHACU-201201
Secondary ID
Status Completed
Phase N/A
First received September 25, 2012
Last updated September 2, 2016
Start date September 2012
Est. completion date November 2014

Study information

Verified date September 2012
Source Shanghai Institute of Acupuncture, Moxibustion and Meridian
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationChina: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date November 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai Institute of Acupuncture-Moxibustion and Merdian Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CDAI Crohn's Disease Activity Index 1 year No
Secondary fMRI Brain activiation tested by BOLD fMRI 1 year No
Secondary IBDQ Inflammatory Bowel Disease Questionnaire 1 year No
Secondary Inflammatory factors Intestinal mucosa of IL-6,IL-17,IL-23,etc 1 and a half years Yes
Secondary Neurotransmitter 5-HT,DA,etc 1 and a half years Yes
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