Effect of Acupuncture on Quiescent Crohn's Disease

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: acupuncture; Other: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04198831

ZYS2015-03

Details and patient eligibility

About

To observe the clinical effect of acupuncture on quiescent Crohn's disease

Full description

To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease

Enrollment: 84 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. aged 16-70;
2. Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
3. Patients with more than 2 disease relapses in the past year;
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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

acupuncture group

Experimental group

Description:

Receiving acupuncture and moxibustion treatment

Treatment:

Other: acupuncture

sham acupuncture group

Sham Comparator group

Description:

Receiving sham acupuncture and sham moxibustion treatment

Treatment:

Other: Sham acupuncture