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

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: 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

Brief Summary:
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Brain functional and structural changes [ Time Frame: Week 12 ]
    measured by functional MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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): NCT04211129


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   
Contact: MD, PhD         
Principal Investigator: Huangan Wu, MD, PhD         
Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine Recruiting
Shanghai, China, 200437
Contact: Guona Li, MD    +862165161782    liguonaaa@163.com   
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Fudan University
Ruijin Hospital
Shanghai Mental Health Center
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: NCT04211129    
Other Study ID Numbers: ZYS2019-02
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 26, 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
brain functional activity
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases