Acupuncture for treating mild to moderate Crohn's disease
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
This study is testing whether acupuncture can help people with mild to moderate Crohn's disease feel better by looking at their symptoms and brain activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian Academic / other |
| Drugs / interventions | methotrexate, prednisone |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT04187820 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of acupuncture on patients with mild to moderate active Crohn's disease. It aims to evaluate how acupuncture influences symptoms of the disease, brain function activity, and the metabolism of tryptophan-kynurenine. The study will also identify brain image markers associated with the therapeutic effects of acupuncture in this patient population. Participants will receive acupuncture treatment while their clinical outcomes and biological markers will be closely monitored.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-70 with mild to moderate active Crohn's disease who have not responded to or cannot tolerate standard medications.
Not a fit: Patients with severe Crohn's disease, serious organic diseases, or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for managing symptoms of Crohn's disease.
How similar studies have performed: Previous studies have shown promising results for acupuncture in managing symptoms of inflammatory bowel diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 16-70; 2. patients with mild or moderate active disease (150 ≤ CDAI \< 450); 3. patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation; 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.
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Shanghai Research Institute of Acupuncture and Meridian — Shanghai, Shanghai Municipality, China (Recruiting)
- Guona Li — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chunhui Bao, MD, PhD
- Email: baochunhui789@126.com
- Phone: +862164395973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.