Back to resultsEffect of Acupuncture on Quiescent Crohn's Disease
Primary Purpose
Inflammatory Bowel Diseases, Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring acupuncture, Crohn's disease
Eligibility Criteria
Inclusion Criteria:
- aged 16-70;
- Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
- Patients with more than 2 disease relapses in the past year;
- 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;
- those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
- those who have never experienced acupuncture;
- patients signing informed consent.
Exclusion Criteria:
- 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;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
- there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
- patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
- there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Sites / Locations
- Shanghai Research Institute of Acupuncture and MeridianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
acupuncture group
sham acupuncture group
Arm Description
Receiving acupuncture and moxibustion treatment
Receiving sham acupuncture and sham moxibustion treatment
Outcomes
Primary Outcome Measures
The proportion of clinical relapse rates
Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
Secondary Outcome Measures
Time of first relapse
Difference in time to first relapse between groups during the trial.
Number of relapses
Difference in the number of relapses between groups during the trial.
Moderate to severe clinical relapse rate
Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.
The mean change of CDAI from baseline
Difference in the mean change of CDAI from baseline between groups
The mean change of serum CRP level from baseline
Difference in the mean change of serum CRP level from baseline between groups
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
The mean change of the Hospital anxiety and depression scale (HADS)
Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.
Full Information
NCT ID
NCT04198831
First Posted
December 11, 2019
Last Updated
April 11, 2023
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Shanghai University of Traditional Chinese Medicine, Ruijin Hospital, Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04198831
Brief Title
Effect of Acupuncture on Quiescent Crohn's Disease
Official Title
Effect of Acupuncture on Quiescent Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Shanghai University of Traditional Chinese Medicine, Ruijin Hospital, Indiana University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To observe the clinical effect of acupuncture on quiescent Crohn's disease
Detailed Description
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease
Keywords
acupuncture, Crohn's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
Receiving acupuncture and moxibustion treatment
Arm Title
sham acupuncture group
Arm Type
Sham Comparator
Arm Description
Receiving sham acupuncture and sham moxibustion treatment
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. 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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.
Primary Outcome Measure Information:
Title
The proportion of clinical relapse rates
Description
Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Time of first relapse
Description
Difference in time to first relapse between groups during the trial.
Time Frame
Week 48
Title
Number of relapses
Description
Difference in the number of relapses between groups during the trial.
Time Frame
Week 48
Title
Moderate to severe clinical relapse rate
Description
Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.
Time Frame
Week 48
Title
The mean change of CDAI from baseline
Description
Difference in the mean change of CDAI from baseline between groups
Time Frame
Week 12, 24, 36 and 48
Title
The mean change of serum CRP level from baseline
Description
Difference in the mean change of serum CRP level from baseline between groups
Time Frame
Week 12, 24, 36 and 48
Title
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
Time Frame
Week 12 and 24
Title
The mean change of the Hospital anxiety and depression scale (HADS)
Description
Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
Time Frame
Week 12 and 24
Title
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Description
Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.
Time Frame
Week 48
Other Pre-specified Outcome Measures:
Title
brain structural and functional changes
Description
brain functional and structural changes reflected by fMRI
Time Frame
Week 12
Title
Intestinal microbiota
Description
Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing.
Time Frame
Week 12
Title
Analysis of the association between gut microbes, brain imaging and behavior
Description
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 CD in remission.
Time Frame
Week 12
Title
Acupuncture efficacy prediction
Description
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 for brain neuroimaging markers that predict the effectiveness of acupuncture in delaying CD disease recurrence.
Time Frame
Week 48
Title
Disease recurrence prediction
Description
Differences in brain structure and functional activity between remitting CD patients with high relapse and remitting CD patients with low relapse as well as healthy subjects were measured, and deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate diagnostic models of the disease and screen for brain imaging markers that predict disease recurrence in remitting CD.
Time Frame
Week 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 16-70;
Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
Patients with more than 2 disease relapses in the past year;
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;
those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
those who have never experienced acupuncture;
patients signing informed consent.
Exclusion Criteria:
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;
severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunhui Bao, MD, PhD
Phone
+862164395973
Email
baochunhui789@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huangan Wu, MD, PhD
Organizational Affiliation
Shanghai Research Institute of Acupuncture and Meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Research Institute of Acupuncture and Meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhui Bao, MD, PhD
Phone
+862164395973
Email
baochunhui789@126.com
First Name & Middle Initial & Last Name & Degree
Huangan Wu, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Acupuncture on Quiescent Crohn's Disease
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