Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Enrolling

Conditions: Intestinal Disorder; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04187820

ZYS2019-01

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Acupuncture group

Experimental group

Description:

Participants receiving acupuncture and mild moxibustion.

Treatment:

Other: acupuncture