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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696838
• Other study ID #: SHACU-201201
• 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

• CAM
• Crohn Disease
• Crohn's Disease

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