Completed

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

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What is being tested

electroacupuncture

+ moxibustion

+ electroacupuncture

Other
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
Last updated: September 5, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01696838
Principal SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
Last updated: September 5, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel DiseasesCrohn Disease

Criteria

6 inclusion criteria required to participate
C-reactive protein(CRP) < 10 mg/l
age 18-50 years
clinical remission (Crohn's Disease Activity Index [CDAI] <= 150) for at least 6 months prior to the study
erythrocyte sedimentation rate (ESR) < 20 mm/h
Show More Criteria
9 exclusion criteria prevent from participating
being pregnant or during lactation
claustrophobia
current or prior history of neurological or psychiatric disease based
current or prior history of neurosurgery, head injury, cerebrovascular
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Electroacupuncture group

Group II

Experimental
Herbs-partitioned moxibustion group

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, ChinaOpen Shanghai Institute of Acupuncture-Moxibustion and Merdian in Google Maps
CompletedOne Study Center