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Effect of Acupuncture on Patients With Crohn's Disease in Remission

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ClinicalTrials.gov Identifier: NCT04211129
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborators:
Fudan University
Ruijin Hospital
Shanghai Mental Health Center
Indiana University School of Medicine
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Tracking Information
First Submitted Date  ICMJE December 22, 2019
First Posted Date  ICMJE December 26, 2019
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Week 12 ]
The mean change in GSRS from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 45.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
  • Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Week 24,36,48,52 ]
    The mean change in GSRS from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 45.
  • Multidimensional fatigue inventory-20 (MFI-20) [ Time Frame: Week 12, 24,36,48,52 ]
    The mean change in MFI-20 from baseline. The higher the score, the worse the condition. The score range from 20 to 100.
  • Pittsburgh sleep quality index (PSQI) [ Time Frame: Week 12, 24,36,48,52 ]
    The mean change in PSQI from baseline. The higher the score, the worse the condition. The score range from 0 to 21.
  • The insomnia severity index (ISI) [ Time Frame: Week 12, 24,36,48,52 ]
    The mean change in ISI from baseline. The higher the score, the worse the condition. The score range from 0 to 28.
  • Crohn's disease activity index (CDAI)score [ Time Frame: Week 12, 24,36,48,52 ]
    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) [ Time Frame: Week 12 and 24. ]
    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) [ Time Frame: Week 12 and 24 ]
    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.
  • The proportion of recurrences [ Time Frame: Week 52 ]
    Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
  • Brain functional and structural changes [ Time Frame: Week 12 ]
    measured by functional MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Acupuncture on Patients With Crohn's Disease in Remission
Official Title  ICMJE Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Brief Summary To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
Detailed Description
  1. Effect of acupuncture on symptoms (functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress)of CD
  2. Effect of acupuncture on brain functional activity of CD
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn Disease
  • Inflammatory Bowel Diseases
Intervention  ICMJE
  • Other: acupuncture
    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.
  • Other: Sham acupuncture
    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.
Study Arms  ICMJE
  • Experimental: acupuncture group
    Receiving acupuncture and moxibustion
    Intervention: Other: acupuncture
  • Sham Comparator: sham acupuncture group
    Receiving sham acupuncture and sham moxibustion
    Intervention: Other: Sham acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. aged 16-70;
  2. patients in remission (CDAI < 150);
  3. 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;
  4. those who did not use TNF alpha and other preparations within 3 months before entering the study;
  5. those who have never experienced acupuncture;
  6. patients signing informed consent.

Exclusion Criteria:

  1. patients who are recently pregnant or in pregnancy or lactation;
  2. patients with serious organic diseases;
  3. patients diagnosed as psychosis;
  4. 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;
  5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
  6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
  7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
  8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chunhui Bao, MD, PhD +862164395973 baochunhui789@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04211129
Other Study ID Numbers  ICMJE ZYS2019-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study Sponsor  ICMJE Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators  ICMJE
  • Fudan University
  • Ruijin Hospital
  • Shanghai Mental Health Center
  • Indiana University School of Medicine
Investigators  ICMJE
Study Chair: Huangan Wu, MD, PhD Shanghai Research Institute of Acupuncture and Meridian
PRS Account Shanghai Institute of Acupuncture, Moxibustion and Meridian
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP