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Effect of Acupuncture on Quiescent Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198831
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
Fudan University
Shanghai University of Traditional Chinese Medicine
Ruijin Hospital
Indiana University School of Medicine
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary:
To observe the clinical effect of acupuncture on quiescent Crohn's disease

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Other: acupuncture Other: Sham acupuncture Not Applicable

Detailed Description:
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Quiescent Crohn's Disease
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture group
Receiving acupuncture and moxibustion treatment
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.

Sham Comparator: sham acupuncture group
Receiving sham acupuncture and sham moxibustion treatment
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.




Primary Outcome Measures :
  1. The proportion of clinical recurrences [ Time Frame: Week 48 ]
    Defined as CDAI > 150 and increased by ≥70 points or need to adjust drug to control active disease.


Secondary Outcome Measures :
  1. Mean time of recurrence [ Time Frame: Week 48 ]
    The mean duration of disease recurrence during follow-up.

  2. The mean change of CDAI from baseline [ Time Frame: Week 12, 24, 36 and 48 ]
    Difference in the mean change of CDAI from baseline between groups

  3. The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 12 and 24 ]
    Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.

  4. The mean change of the Hospital anxiety and depression scale (HADS) [ Time Frame: Week 12 and 24 ]
    Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.

  5. The mean change of Crohn's disease endoscopic index of severity (CDEIS) [ Time Frame: Week 48 ]
    Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.


Other Outcome Measures:
  1. brain structural and functional changes [ Time Frame: Week 12 ]
    brain functional and structural changes reflected by fMRI

  2. Intestinal microbiota [ Time Frame: Week 12 ]
    Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 anti-TNF alpha and other agents 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198831


Contacts
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Contact: Chunhui Bao, MD, PhD +862164395973 baochunhui789@126.com

Locations
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China
Shanghai Research Institute of Acupuncture and Meridian Recruiting
Shanghai, China, 200030
Contact: Chunhui Bao, MD, PhD    +862164395973    baochunhui789@126.com   
Principal Investigator: Huangan Wu, MD, PhD         
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Fudan University
Shanghai University of Traditional Chinese Medicine
Ruijin Hospital
Indiana University School of Medicine
Investigators
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Study Chair: Huangan Wu, MD, PhD Shanghai Research Institute of Acupuncture and Meridian

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Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT04198831    
Other Study ID Numbers: ZYS2015-03
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
acupuncture
Crohn's disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases