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Clinical Trials in China / NCT04187820
Recruiting Not applicable

Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

NCT04187820 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Phase
Not applicable
Started
2019-06-01
Last updated
2025-05-14

Condition(s) studied

Intestinal DisorderInflammatory Bowel DiseasesCrohn Disease

Investigational drug(s) / intervention(s)

acupuncture

acupuncture: Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shanghai Research Institute of Acupuncture and Meridian Shanghai Shanghai Municipality Recruiting
Guona Li Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04187820 on ClinicalTrials.gov ↗ ← All trials in China