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Effect of Acupuncture on Mild to Moderate Active 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: NCT04187820
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 24, 2019
Sponsor:
Collaborators:
Fudan University
Shanghai University of Traditional Chinese Medicine
Shanghai Jiao Tong University School of Medicine
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 Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD

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

Detailed Description:
  1. Effect of acupuncture on symptoms of CD
  2. Effect of acupuncture on brain functional activity of CD
  3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
  4. Screen the brain image markers of acupuncture in the treatment of CD

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture group
Participants receiving acupuncture and mild 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. In the acupuncture group, 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.




Primary Outcome Measures :
  1. Clinical remission [ Time Frame: Week 12 ]
    Crohn's disease activity index (CDAI)less than 150 and decreased more than 70


Secondary Outcome Measures :
  1. Clinical remission [ Time Frame: Week 24, 36 and 48 ]
    Crohn's disease activity index (CDAI) less than 150 and decreased more than 70

  2. Clinical response [ Time Frame: Week 12, 24, 36 and 48 ]
    Crohn's disease activity index (CDAI) decreased more than 70

  3. Crohn's disease activity index (CDAI)score [ Time Frame: Week 12, 24, 36 and 48 ]
    The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.

  4. laboratory test [ Time Frame: Week 12, 24, 36 and 48 ]
    serum C-reactive protein (CRP) level

  5. laboratory test [ Time Frame: Week 12, 24, 36 and 48 ]
    Erythrocyte sedimentation rate (ESR)

  6. laboratory test [ Time Frame: Week 12, 24, 36 and 48 ]
    Platelet count

  7. 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.

  8. Crohn's disease endoscopic index of severity (CDEIS) [ Time Frame: Week 48 ]
    The mean change in CDEIS from baseline

  9. 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.

  10. The proportion of recurrences [ Time Frame: Week 48 ]
    Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.

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

  12. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal Indoleamine2,3dioxygenase 1 (IDO1)level

  13. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal Tryptophan (TRP) level

  14. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal kynurenine (KYN)level

  15. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal kynurenic acid (KYNA) level

  16. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal quinolinic acid (QUIN) level

  17. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal IFN-gamma level

  18. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal IL-1beta level

  19. Plasma and intestinal TRP-KYN metabolism level [ Time Frame: Week 12 ]
    Plasma and intestinal IL-18 level



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 with mild or moderate active disease (150 ≤ CDAI < 450);
  3. patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
  4. 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;
  5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
  6. those who have never experienced acupuncture;
  7. 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): NCT04187820


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

Locations
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China, Shanghai
Shanghai Research Institute of Acupuncture and Meridian Recruiting
Shanghai, Shanghai, China, 200030
Contact: Chunhui Bao, Doctor    +862164395973    baochunhui789@126.com   
Principal Investigator: Huangan Wu, Doctor         
China
Guona Li Recruiting
Shanghai, China, 2000
Contact: Guona Li    +862465161782    liguonaaa@163.com   
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Fudan University
Shanghai University of Traditional Chinese Medicine
Shanghai Jiao Tong University School of Medicine
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: NCT04187820    
Other Study ID Numbers: ZYS2019-01
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 24, 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
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases