Acupuncture to prevent Crohn's disease relapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of acupuncture in delaying the recurrence of Crohn's disease (CD) by focusing on the Shaoyang pivot mechanism. It builds on previous findings that acupuncture is a safe and effective treatment for CD, aiming to enhance its therapeutic effects through a deeper understanding of the brain-gut axis dysfunction associated with the condition. Participants will receive specific acupuncture interventions designed to nourish the spleen and kidney while harmonizing the body's energy. The study will analyze various indicators to explore the mechanisms behind acupuncture's efficacy in treating CD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. patients with clinical diagnosis consistent with CD;
2. aged 16-75;
3. patients in remission (CDAI \< 150 and CRP \< 5mg/l, or Faecal calprotectin \< 50μg/g, or no ulcer under endoscopy);
4. patients with frequent disease recurrences (≥2) in the past years;
5. 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);
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 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.

Where it's running

• Shanghai Research Institute of Acupuncture and Meridian
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Bao Chunhui, MD, PhD — Shanghai University of TCM
• Study coordinator: Bao Chunhui, MD, PhD
• Email: baochunhui789@126.com
• Phone: +862164395973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.