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

NCT ID: NCT01696838

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-11-30

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.

Conditions

Crohn's Disease; CAM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EA group

Electroacupuncture group

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: 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.

moxibustion

Intervention Type: OTHER

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

MOX group

Herbs-partitioned moxibustion group

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: 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.

moxibustion

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

moxibustion

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

Intervention Type: OTHER

Other Intervention Names

acupuncture; herbs-partitioned moxibustion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wu Huangan, PhD

Role: STUDY_CHAIR

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Locations

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHACU-201201

Identifier Type: -

Identifier Source: org_study_id