Crohn's DiseaseNCT01696838
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI
A study testing electroacupuncture and moxibustion in people with Crohn's Disease and CAM, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, CAM
- What is being tested?
- electroacupuncture and moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- claustrophobia;
- presence of metallic implants in the body;
- being pregnant or during lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture-Moxibustion and Merdian
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(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.
Read the 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
- Being tested
- electroacupuncture, moxibustion
- Keywords
- Crohn's disease, acupuncture, moxibustion, fMRI, Gut
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
Also called acupuncture
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.
moxibustionOther
Also called herbs-partitioned moxibustion
patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EA group | Experimental | Electroacupuncture group Receives: Other: electroacupuncture; Other: moxibustion |
| MOX group | Experimental | Herbs-partitioned moxibustion group Receives: Other: electroacupuncture; Other: moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDAI
Crohn's Disease Activity Index
Measured: 1 year
Secondary outcomes (4)
fMRI
Brain activiation tested by BOLD fMRI
Measured: 1 year
IBDQ
Inflammatory Bowel Disease Questionnaire
Measured: 1 year
Inflammatory factors
Intestinal mucosa of IL-6,IL-17,IL-23,etc
Measured: 1 and a half years
Neurotransmitter
5-HT,DA,etc
Measured: 1 and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Huangan, PhD, Study chair, Shanghai Institute of Acupuncture, Moxibustion and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696838
- Sponsor's protocol ID
- SHACU-201201
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)
- ClinicalTrials.gov ID
- NCT01696838
- Acronym / sponsor ID
- SHACU-201201
- Conditions
- Crohn's Disease, CAM
- Keywords
- Crohn's disease, acupuncture, moxibustion, fMRI, Gut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA group | Experimental | Other: electroacupuncture, Other: moxibustionElectroacupuncture group |
| MOX group | Experimental | Other: electroacupuncture, Other: moxibustionHerbs-partitioned moxibustion group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureAlso: acupuncturePatients 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 | EA group, MOX group |
| moxibustionAlso: herbs-partitioned moxibustionpatients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks. | Other | EA group, MOX group |
Primary outcome
CDAI
Time frame: 1 year
Crohn's Disease Activity Index
4 secondary outcomes
fMRI
Time frame: 1 year
IBDQ
Time frame: 1 year
Inflammatory factors
Time frame: 1 and a half years
Neurotransmitter
Time frame: 1 and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu Huangan, PhD study chair
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and moxibustion in people with Crohn's Disease and CAM, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDAI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.