Effect of Acupuncture on Quiescent Crohn's Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Other: Sham acupuncture; Other: acupuncture

• Registration Number: NCT04198831
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham acupuncture group	Sham acupuncture	Receiving sham acupuncture and sham moxibustion treatment
acupuncture group	acupuncture	Receiving acupuncture and moxibustion treatment

Primary Outcome Measures

Name	Time	Method
The proportion of clinical relapse rates	Week 48	Defined as a CDAI score of \>150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.

Secondary Outcome Measures

Name	Time	Method
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)	Week 12 and 24	Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
Number of relapses	Week 48	Difference in the number of relapses between groups during the trial.
Time of first relapse	Week 48	Difference in time to first relapse between groups during the trial.
Moderate to severe clinical relapse rate	Week 48	Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.
The mean change of serum CRP level from baseline	Week 12, 24, 36 and 48	Difference in the mean change of serum CRP level from baseline between groups
The mean change of CDAI from baseline	Week 12, 24, 36 and 48	Difference in the mean change of CDAI from baseline between groups
The mean change of the Hospital anxiety and depression scale (HADS)	Week 12 and 24	Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
The mean change of Crohn's disease endoscopic index of severity (CDEIS)	Week 48	Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.

Trial Locations

Locations (1)

Shanghai Research Institute of Acupuncture and Meridian; 🇨🇳 Shanghai, China