Effect of Acupuncture on Mild to Moderate Active Crohn's Disease
Recruiting · NCT04187820 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
View the official record on ClinicalTrials.gov →Interventions studied
acupuncture
What this trial is about
To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD
Who can take part
Age range
16 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- aged 16-70;
- patients with mild or moderate active disease (150 ≤ CDAI \< 450);
- patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
- 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;
- those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
- 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 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;
- 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
2 locations listed.
- Guona Li - Shanghai, China
- Shanghai Research Institute of Acupuncture and Meridian - Shanghai, Shanghai Municipality, China