Actively Recruiting

Phase Not Applicable
Age: 16Years - 75Years
All Genders
ID06553053

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

Led by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Updated on 2026-04-13

106

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Lead Sponsor

R

Ruijin Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve the effectiveness of acupuncture in delaying the return of Crohn's disease (CD) symptoms and to understand how acupuncture enhances treatment through the brain-gut axis. It builds on prior studies focusing on spleen and stomach support by exploring acupuncture targeting the Shaoyang pivot mechanism for better results. Brain-gut axis dysfunction plays a key role in CD, and this trial investigates multiple pathways involved in this process. Participants receive one of two acupuncture treatments combined with mild moxibustion, performed twice weekly for 12 weeks, followed by a 40-week follow-up. One group receives acupuncture aimed at "harmonizing Shaoyang, nourishing spleen and kidney with warmth," while the other group receives acupuncture focused on "nourishing spleen and kidney with warmth." Each treatment session lasts 30 minutes, where acupuncture and moxibustion are performed simultaneously, using specific acupoint combinations alternated between two sets. Throughout the study, participants are assessed regularly for disease recurrence and activity using clinical indexes such as the Crohn's Disease Activity Index (CDAI) and patient-reported outcomes over 52 weeks. Laboratory tests, inflammation markers, colonoscopy or MR imaging, quality of life questionnaires, and mood assessments are conducted at multiple time points. Researchers monitor the proportion and timing of disease relapses, aiming to better understand acupuncture's impact and mechanisms in CD management.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with clinical diagnosis consistent with Crohn's disease
  • Aged between 16 and 75 years
  • In remission with CDAI less than 150 and low inflammatory markers or no ulcers under endoscopy
  • Experienced two or more disease relapses in recent years
  • Not currently taking medication or only certain drugs within specified doses and durations
  • Have never received acupuncture before
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Currently pregnant, recently pregnant, or breastfeeding
  • Have serious organic diseases
  • Diagnosed with psychosis
  • Have multiple diseases requiring long-term medication affecting trial observation
  • Have severe skin, eye, thromboembolic, or serious extraintestinal diseases
  • Have serious intestinal complications such as fistula, abscess, stenosis, obstruction, or perforation
  • Have had abdominal or gastrointestinal surgery within the past six months with short bowel syndrome
  • Have skin diseases or defects at acupuncture or moxibustion sites preventing treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive acupuncture and mild moxibustion treatments twice per week for 12 weeks, targeting specific acupoints to help manage Crohn's disease.

Approximately 24 visits (in-person, twice weekly)

Follow-up

Duration - 40 weeks

Participants are followed for 40 weeks after treatment to monitor the effects and any recurrence of Crohn's disease symptoms.

Visits at Weeks 24, 36, and 52 for assessments

Trial Site Locations

Total: 1 location

1

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, China

Actively Recruiting

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Research Team

B

Bao Chunhui, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Epidemiology of Inflammatory Bowel Disease from 1981 to 2014: Results from a Territory-Wide Population-Based Registry in Hong Kong.

Siew C Ng, Wai Keung Leung, Hai Yun Shi...

https://pubmed.ncbi.nlm.nih.gov/27416041

Biologic Therapies and Risk of Infection and Malignancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis.

Stefanos Bonovas, Gionata Fiorino, Mariangela Allocca...

https://pubmed.ncbi.nlm.nih.gov/27189910

Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial.

Chunhui Bao, Luyi Wu, Di Wang...

https://pubmed.ncbi.nlm.nih.gov/35198926