Status:
RECRUITING
Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Lead Sponsor:
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Crohn's Disease Relapse
Inflammatory Bowel Diseases
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief Summary
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
Detailed Description
Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we ...
Eligibility Criteria
Inclusion
- patients with clinical diagnosis consistent with CD;
- aged 16-75;
- patients in remission (CDAI \< 150 and CRP \< 5mg/l, or Faecal calprotectin \< 50μg/g, or no ulcer under endoscopy);
- patients with frequent disease recurrences (≥2) in the past years;
- patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
- those who have never experienced acupuncture;
- patients signing informed consent.
Exclusion
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients 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;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
- there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
- patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
- there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06553053
Start Date
August 13 2024
End Date
December 31 2028
Last Update
August 15 2024
Active Locations (1)
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1
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, China