Effect of Acupuncture on Mild to Moderate Active Crohn's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
About this trial
To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged 16-70;
patients with mild or moderate active disease (150 ≤ CDAI < 450);
patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
Disqualifiers
patients who are recently pregnant or in pregnancy or lactation;
patients with serious organic diseases;
patients diagnosed as psychosis;
patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
Trial design
Design model
Single group
Treatments tested in this trial
acupuncture
Other interventionPatients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Acupuncture groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical remission
Crohn's disease activity index （CDAI）less than 150 and decreased more than 70
Time frame
Week 12Secondary outcomes
1
Clinical remission
Crohn's disease activity index （CDAI） less than 150 and decreased more than 70
Time frame
Week 24, 36 and 482
Clinical response
Crohn's disease activity index （CDAI） decreased more than 70
Time frame
Week 12, 24, 36 and 483
Crohn's disease activity index （CDAI）score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Time frame
Week 12, 24, 36 and 484
laboratory test
serum C-reactive protein (CRP) level
Time frame
Week 12, 24, 36 and 48Other outcomes
1
Analysis of intestinal microbes
Application of 16S sequencing to analyze the gut microbial composition, structure and diversity of patients.
Time frame
Week 122
Analysis of the association between gut microbes, brain imaging and behavior
The pearson correlation and linear regression models were applied to establish the association between gut microbes, brain function and structure and behavior in an attempt to explore the relationship between the gut microbe-gut-brain axis in patients with active CD.
Time frame
Week 123
Acupuncture efficacy prediction
Deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate an acupuncture efficacy prediction model based on MRI changes in high and low response patients in the acupuncture group, and to screen brain neuroimaging markers that predict the effective relief of CD disease activity by acupuncture.
Time frame
Week 484
Disease activity prediction
Differences in brain structure and functional activity between active CD patients and remitting CD patients as well as healthy subjects are measured, and deep learning algorithms such as artificial neural networks and support vector machines are applied to construct and validate disease diagnostic models and screen brain imaging markers that predict CD disease activity.
Time frame
Week 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Lead sponsor
Fudan University
Collaborator
Shanghai University of Traditional Chinese Medicine
Collaborator
Shanghai Jiao Tong University School of Medicine
Collaborator
Indiana University
Collaborator
Source ClinicalTrials.gov