Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

April 7, 2026 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Research Institute of Acupuncture and Meridian
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients with clinical diagnosis consistent with CD;
  2. aged 16-75;
  3. patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
  4. patients with frequent disease recurrences (≥2) in the past years;
  5. patients were not taking medication or were only taking one or more of the following drugs: [mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
  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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth"
Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
Active Comparator: Control group
Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth"
Other: "Nourishing spleen and kidney with warmth" Acupuncture Group
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of recurrences
Time Frame: Week 52
Defined as CDAI > 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of recurrences
Time Frame: Week 52
Total number of recurrences. The median number will be counted for both groups.
Week 52
Time of recurrences
Time Frame: Week 52
Time to first recurrence will be counted for both groups.
Week 52
Crohn's disease activity index （CDAI）score
Time Frame: Week 0, 6, 12, 24, 36 and 52
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Week 0, 6, 12, 24, 36 and 52
Patient Reported Outcome （PRO2）
Time Frame: Week 0, 6, 12, 24, 36 and 52
The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week.
Week 0, 6, 12, 24, 36 and 52
First laboratory tests
Time Frame: Week 0, 6, 12, 24, 36 and 52
serum C-reactive protein (CRP)
Week 0, 6, 12, 24, 36 and 52
Second laboratory tests
Time Frame: Week 0, 6, 12, 24, 36 and 52
erythrocyte sedimentation rate (ESR)
Week 0, 6, 12, 24, 36 and 52
Third laboratory tests
Time Frame: Week 0, 6, 12, 24, 36 and 52
platelet count (PLT)
Week 0, 6, 12, 24, 36 and 52
Inflammatory bowel disease questionnaire (IBDQ)
Time Frame: Week 0, 12, 24, 36 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.
Week 0, 12, 24, 36 and 52
Hospital anxiety and depression scale (HADS)
Time Frame: Week 0, 12, 24, 36 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.
Week 0, 12, 24, 36 and 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: Week 0, 12, 24, 36 and 52
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Week 0, 12, 24, 36 and 52
Colonoscopy or small bowel MR evaluation
Time Frame: Week 0 and 52
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Week 0 and 52
Expectation of acupuncture treatment
Time Frame: Week 0
measured by acupuncture treatment effectiveness expectation questionnaire
Week 0
Blind questionnaire
Time Frame: Week 6 and 12
measured by patients guessing their grouping
Week 6 and 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of acupuncture on brain network connectivity properties
Time Frame: Week 0 and 12
Gray matter structure of the brain，functional connectivity and network properties of brain networks and local activity in brain regions were measured in an attempt to analyze the correlation between changes in these indicators after acupuncture intervention and the efficacy of acupuncture.
Week 0 and 12
Salivary cortisol
Time Frame: Week 0 and 12
Salivary cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Week 0 and 12
α-Salivary Amylase
Time Frame: Week 0 and 12
α-Salivary Amylase is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Week 0 and 12
Serum cortisol
Time Frame: Week 0 and 12
Serum cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Week 0 and 12
Effect of acupuncture on autonomic nervous activity
Time Frame: Week 0 and 12
The effect of acupuncture on autonomic function was recorded by DMS300-4AL.
Week 0 and 12
Effect of acupuncture on intestinal inflammation levels function
Time Frame: Week 0 and 12
Intestinal inflammation levels are measured by C-reactive protein and plasma concentrations of tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and IL-6.
Week 0 and 12
Effect of acupuncture on intestinal mucosal barrier function
Time Frame: Week 0 and 12
Intestinal mucosal barrier function are measured by concentrations of lipopolysaccharide (LPS), Diamine oxidase (DAO) and D-lactate.
Week 0 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Collaborators

Ruijin Hospital

Investigators

  • Principal Investigator: Bao Chunhui, MD, PhD, Shanghai University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 10, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYS2024-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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