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Phase Not Applicable
Age: 16Years - 70Years
All Genders
Healthy Volunteers
ID04187820

Acupuncture Treatment for Mild to Moderate Active Crohns Disease and Its Effects on Brain and Metabolism

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 Crohns 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 Crohns 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

Age: 16Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

C

Chunhui Bao, MD, PhD

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