Effect of Acupuncture on Patients With Crohn's Disease in Remission

Not Applicable

Suspended

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

• Registration Number: NCT04211129
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

Detailed Description

1. Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD

2. Effect of acupuncture on brain functional activity of CD

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2019-12-22
• Study First Posted: 2019-12-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. aged 16-70;
2. patients in remission (CDAI < 150);
3. 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;
4. those who did not use TNF alpha and other preparations within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham acupuncture group	Sham acupuncture	Receiving sham acupuncture and sham moxibustion
acupuncture group	acupuncture	Receiving acupuncture and moxibustion

Primary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory (BFI-C)	Week 12	The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.

Secondary Outcome Measures

Name	Time	Method
Inflammatory bowel disease questionnaire (IBDQ)	Week 12, 24 and 52	The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
The proportion of recurrences	Week 52	Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Week 12, 24,52	The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Hospital anxiety and depression scale (HADS)	Week 12, 24 and 52	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.
Brief Fatigue Inventory (BFI-C)	Week 24,52	The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Crohn's disease activity index （CDAI）score	Week 12, 24,36,48,52	The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Generalized Anxiety Disorder (GAD-7)	Week 12, 24 and 52	The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Brain functional and structural changes	Week 12	measured by functional MRI
Laboratory tests	Week 12, 24, 36, and 52	Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)
Patient Health Questionnaire Depression Scale (PHQ-9)	Week 12, 24 and 52	The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27.
Colonoscopy or small bowel MR evaluation	Week 52	measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)

Trial Locations

Locations (2)

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

Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine; 🇨🇳 Shanghai, China