Effect of Acupuncture on Crohn's Disease in Remission: a Multi-Center Randomized Controlled Trial

Not Applicable

• Conditions: Crohn's disease

• Registration Number: ITMCTR2000003559
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients whose clinical diagnosis is consistent with CD;
(2) Age 16-75 years old;
(3) Patients whose disease is in remission (CDAI<150);
(4) Patients whose disease has relapsed more than twice in the past year;
(5) Not taking the drug or taking one or more of the following drugs: [Mesalazine (<=4g/d), prednisone (<=15mg/d), azathioprine (<=1mg/kg/d)] ; And prednisone and mesalamine have been taken for at least one month, and azathioprine has been taken for at least 3 months;
(5) Those who have not used biological agents within 3 months before entering the study;
(6) Those who have never had acupuncture experience;
(7) Patients who understand the study and sign an informed consent form.

Exclusion Criteria

(1) Patients who have recently become pregnant or are pregnant or breastfeeding;
(2) Patients with severe organic disease;
(3) Patients diagnosed with mental illness;
(4) Patients who suffer from multiple diseases at the same time and take other drugs for a long time and may affect the observation of this clinical trial;
(5) Those who have serious extraintestinal manifestations such as severe skin diseases (such as erythema nodules, pyoderma gangrenosum, etc.), ocular diseases (such as iritis, uveitis, etc.), thromboembolic diseases, etc.;
(6) Complications such as severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal disease (perianal abscess, etc.), gastrointestinal bleeding, intestinal perforation, etc.;
(7) Those who have short bowel syndrome, who have undergone abdominal or gastrointestinal surgery in the past six months;
(8) Those who have skin diseases or defects in the selected area of acupuncture and moxibustion cannot be acupuncture.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate of patients at 24 weeks;

Secondary Outcome Measures

Name	Time	Method
Recurrence time and number of recurrences in 24 weeks;IBDQ;CDAI;Laboratory inspection and evaluation;HADS;