Actively Recruiting
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Led by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Updated on 2025-05-14
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of acupuncture on people with mild to moderate active Crohn's disease. The study aims to see how acupuncture affects symptoms, brain activity, and the metabolism of certain substances (TRY-KYN) related to the brain-gut connection. They also want to identify brain imaging markers linked to acupuncture treatment in Crohn's disease. The study is led by the Shanghai Institute of Acupuncture, Moxibustion and Meridian. Participants will receive acupuncture and mild moxibustion treatments three times a week for 12 weeks. Specific points on the body (such as CV12, ST37, SP6, and others) will be used for acupuncture and moxibustion, with a device applied to ensure the sensation of treatment and maintain the temperature of moxibustion points. After the 12-week treatment phase, participants will be followed for an additional 36 weeks to monitor the effects. During the study, participants will be evaluated at various times up to 48 weeks. Researchers will measure clinical remission, symptom improvements, disease activity scores, laboratory tests, quality of life questionnaires, anxiety and depression scales, and endoscopic severity. Brain imaging and metabolism levels of TRP-KYN in plasma and intestines will also be assessed. Safety and recurrence rates will be monitored throughout the study.
CONDITIONS
Brief Title
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 to 70 years
- Mild or moderate active Crohn's disease (CDAI between 150 and less than 450)
- Not responsive, intolerant, dependent on, or refused to use certain medications including mesalazine, glucocorticoids, immunomodulators, or anti-TNF alpha preparations
- Either not taking medication or taking only prednisone (up to 15 mg/day), azathioprine (up to 1 mg/kg/day), methotrexate (up to 15 mg/week), or mesalazine (up to 4 g/day) with specified minimum treatment durations
- No use of anti-TNF alpha or other agents within 3 months before study entry
- Never had acupuncture before
- Signed informed consent
You will not qualify if you...
- Currently pregnant, recently pregnant, or breastfeeding
- Having serious organic diseases
- Diagnosed with psychosis
- Taking antibiotics, probiotics, traditional Chinese medicine, or other drugs that may affect study results
- Having severe skin diseases, eye diseases, thromboembolic diseases, or serious extraintestinal Crohn's manifestations
- Having serious intestinal complications such as fistula, abscess, stenosis, obstruction, hemorrhage, or perforation
- History of abdominal or gastrointestinal surgery within the past 6 months
- Skin diseases or defects at acupuncture or moxibustion sites preventing treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive acupuncture and mild moxibustion 3 times per week for 12 weeks targeting specific acupoints with controlled temperature moxibustion.
Approximately 36 treatment visits (in-person)
Duration - 36 weeks
Participants are followed up to monitor clinical remission and response, brain function, and metabolism levels after treatment ends.
Visits at Weeks 24, 36, and 48 for assessments
Trial Site Locations
Total: 2 locations
1
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Guona Li
Shanghai, China, 2000
Actively Recruiting
Research Team
C
Chunhui Bao, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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