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

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Intestinal Disorder
• Interventions: Other: acupuncture

• Registration Number: NCT04187820
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture group	acupuncture	Participants receiving acupuncture and mild moxibustion.

Primary Outcome Measures

Name	Time	Method
Clinical remission	Week 12	Crohn's disease activity index （CDAI）less than 150 and decreased more than 70

Secondary Outcome Measures

Name	Time	Method
Clinical remission	Week 24, 36 and 48	Crohn's disease activity index （CDAI） less than 150 and decreased more than 70
Clinical response	Week 12, 24, 36 and 48	Crohn's disease activity index （CDAI） decreased more than 70
Crohn's disease activity index （CDAI）score	Week 12, 24, 36 and 48	The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
laboratory test	Week 12, 24, 36 and 48	Platelet count
Crohn's disease endoscopic index of severity (CDEIS)	Week 48	The mean change in CDEIS from baseline
Brain functional and structural changes	Week 12	measured by functional MRI
Inflammatory bowel disease questionnaire (IBDQ)	Week 12 and 24	The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Hospital anxiety and depression scale (HADS)	Week 12 and 24	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.
The proportion of recurrences	Week 48	Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Plasma and intestinal TRP-KYN metabolism level	Week 12	Plasma and intestinal IL-18 level

Trial Locations

Locations (2)

Shanghai Research Institute of Acupuncture and Meridian; 🇨🇳 Shanghai, Shanghai, China

Guona Li; 🇨🇳 Shanghai, China