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Clinical Trial NCT04187820 for Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effect of Acupuncture on Mild to Moderate Active Crohn's Disease 60

Recruiting
Clinical Trial NCT04187820 is an interventional study for Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease that is recruiting. It started on 1 June 2019 with plans to enroll 60 participants. Led by Shanghai Institute of Acupuncture, Moxibustion and Meridian, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 14 May 2025.
Brief 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
Detailed Description
  1. Effect of acupuncture on symptoms of CD
  2. Effect of acupuncture on brain functional activity of CD
  3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
  4. Screen the brain image markers of acupuncture in the treatment of CD
Official Title

Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Conditions
Intestinal DisorderInflammatory Bowel DiseasesCrohn Disease
Other Study IDs
  • ZYS2019-01
NCT ID Number
NCT04187820
Start Date (Actual)
2019-06-01
Last Update Posted
2025-05-14
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
acupuncture
Crohn's disease
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAcupuncture group
Participants receiving acupuncture and mild moxibustion.
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 acup...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Clinical remission
Crohn's disease activity index （CDAI）less than 150 and decreased more than 70
Week 12
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Clinical remission
Crohn's disease activity index （CDAI） less than 150 and decreased more than 70
Week 24, 36 and 48
Clinical response
Crohn's disease activity index （CDAI） decreased more than 70
Week 12, 24, 36 and 48
Crohn's disease activity index （CDAI）score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Week 12, 24, 36 and 48
laboratory test
serum C-reactive protein (CRP) level
Week 12, 24, 36 and 48
laboratory test
Erythrocyte sedimentation rate (ESR)
Week 12, 24, 36 and 48
laboratory test
Platelet count
Week 12, 24, 36 and 48
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Week 12 and 24
Crohn's disease endoscopic index of severity (CDEIS)
The mean change in CDEIS from baseline
Week 48
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Week 12 and 24
The proportion of recurrences
Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Week 48
Brain functional and structural changes
measured by functional MRI
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Indoleamine2,3dioxygenase 1 （IDO1）level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Tryptophan (TRP) level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenine （KYN）level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenic acid （KYNA） level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal quinolinic acid (QUIN) level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IFN-gamma level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-1beta level
Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-18 level
Week 12
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
16 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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.
Shanghai Institute of Acupuncture, Moxibustion and Meridian logoShanghai Institute of Acupuncture, Moxibustion and Meridian
Study Central Contact
Contact: Chunhui Bao, MD, PhD, +862164395973, [email protected]
2 Study Locations in 1 Countries

Shanghai Municipality

Shanghai Research Institute of Acupuncture and Meridian, Shanghai, Shanghai Municipality, 200030, China
Chunhui Bao, Doctor, Contact, +862164395973, [email protected]
Huangan Wu, Doctor, Principal Investigator
Recruiting
Guona Li, Shanghai, 2000, China
Guona Li, Contact, +862465161782, [email protected]
Recruiting