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

Last updated: April 16, 2024
Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

Sham acupuncture

acupuncture

Clinical Study ID

NCT04211129
ZYS2019-02
  • Ages 16-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 followingdrugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) ormesalazine (≤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 enteringthe study;
  5. those who have never experienced acupuncture;
  6. patients signing informed consent.

Exclusion

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 otherdrugs at the same time, or who suffer from multiple diseases and need to take otherdrugs 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.), eyediseases (such as iritis, uveitis, etc.), thromboembolic diseases and other seriousextraintestinal manifestations;
  6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis andobstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation andother complications;
  7. patients with short bowel syndrome who have undergone abdominal or gastrointestinalsurgery in the past half a year;
  8. there are skin diseases or defects in the selected area of acupuncture and moxibustionthat cannot be performed.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Sham acupuncture
Phase:
Study Start date:
July 01, 2019
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Shanghai Research Institute of Acupuncture and Meridian

    Shanghai, 200030
    China

    Active - Recruiting

  • Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine

    Shanghai, 200437
    China

    Active - Recruiting

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