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

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Enrolling

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Sham acupuncture; Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04211129

ZYS2019-02

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 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;
4. those who did not use TNF alpha and other preparations within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. 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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60 participants in 2 patient groups

acupuncture group

Experimental group

Description:

Receiving acupuncture and moxibustion

Treatment:

Other: acupuncture

sham acupuncture group

Sham Comparator group

Description:

Receiving sham acupuncture and sham moxibustion

Treatment:

Other: Sham acupuncture