Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Recruiting · NCT06553053 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
View the official record on ClinicalTrials.gov →Interventions studied
"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group"Nourishing spleen and kidney with warmth" Acupuncture Group
What this trial is about
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.
Who can take part
Age range
16 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Shanghai Research Institute of Acupuncture and Meridian - Shanghai, China