Back to resultsEffect of Acupuncture on Patients With Crohn's Disease in Remission
Primary Purpose
Crohn Disease, Inflammatory Bowel Diseases
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 Crohn Disease focused on measuring acupuncture, Crohn's disease, brain functional activity
Eligibility Criteria
Inclusion Criteria:
- aged 16-70;
- patients in remission (CDAI < 150);
- 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 TNF alpha and other preparations 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
- Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicineRecruiting
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
Receiving sham acupuncture and sham moxibustion
Outcomes
Primary Outcome Measures
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Secondary Outcome Measures
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
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.
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Patient Health Questionnaire Depression Scale (PHQ-9)
The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27.
Generalized Anxiety Disorder (GAD-7)
The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
The proportion of recurrences
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Brain functional and structural changes
measured by functional MRI
Colonoscopy or small bowel MR evaluation
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Laboratory tests
Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)
Full Information
NCT ID
NCT04211129
First Posted
December 22, 2019
Last Updated
April 11, 2023
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Ruijin Hospital, Shanghai Mental Health Center, Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04211129
Brief Title
Effect of Acupuncture on Patients With Crohn's Disease in Remission
Official Title
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Ruijin Hospital, Shanghai Mental Health Center, 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 therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
Detailed Description
Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
Effect of acupuncture on brain functional activity of CD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases
Keywords
acupuncture, Crohn's disease, brain functional activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
Receiving acupuncture and moxibustion
Arm Title
sham acupuncture group
Arm Type
Sham Comparator
Arm Description
Receiving sham acupuncture and sham moxibustion
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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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
Brief Fatigue Inventory (BFI-C)
Description
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Brief Fatigue Inventory (BFI-C)
Description
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Time Frame
Week 24,52
Title
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Time Frame
Week 12, 24,52
Title
Crohn's disease activity index （CDAI）score
Description
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, 24,36,48,52
Title
Inflammatory bowel disease questionnaire (IBDQ)
Description
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Time Frame
Week 12, 24 and 52
Title
Hospital anxiety and depression scale (HADS)
Description
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time Frame
Week 12, 24 and 52
Title
Patient Health Questionnaire Depression Scale (PHQ-9)
Description
The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27.
Time Frame
Week 12, 24 and 52
Title
Generalized Anxiety Disorder (GAD-7)
Description
The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time Frame
Week 12, 24 and 52
Title
The proportion of recurrences
Description
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Time Frame
Week 52
Title
Brain functional and structural changes
Description
measured by functional MRI
Time Frame
Week 12
Title
Colonoscopy or small bowel MR evaluation
Description
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Time Frame
Week 52
Title
Laboratory tests
Description
Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)
Time Frame
Week 12, 24, 36, and 52
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 in remission (CDAI < 150);
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 TNF alpha and other preparations 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
MD, PhD
First Name & Middle Initial & Last Name & Degree
Huangan Wu, MD, PhD
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
City
Shanghai
ZIP/Postal Code
200437
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guona Li, MD
Phone
+862165161782
Email
liguonaaa@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Acupuncture on Patients With Crohn's Disease in Remission
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