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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- aged 16-70;
- patients in remission (CDAI < 150);
- 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;
- those who did not use TNF alpha and other preparations within 3 months before enteringthe study;
- those who have never experienced acupuncture;
- patients signing informed consent.
Exclusion
Exclusion Criteria:
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- 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;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eyediseases (such as iritis, uveitis, etc.), thromboembolic diseases and other seriousextraintestinal manifestations;
- there are serious intestinal fistula, abdominal abscess, intestinal stenosis andobstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation andother complications;
- patients with short bowel syndrome who have undergone abdominal or gastrointestinalsurgery in the past half a year;
- 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
Connect with a study center
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, 200030
ChinaActive - Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
Shanghai, 200437
ChinaActive - Recruiting
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