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

NCT04187820 | Recruiting DMC

• 1 other identifier: ZYS2019-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Intestinal Disorder; Inflammatory Bowel Diseases; Crohn Disease

Keywords

acupuncture; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Crohn's disease activity index （CDAI）less than 150 and decreased more than 70

  Week 12

Secondary Outcomes (19)

• Clinical remission

  Week 24, 36 and 48

• Clinical response

  Week 12, 24, 36 and 48

• Crohn's disease activity index （CDAI）score

  Week 12, 24, 36 and 48

• laboratory test

  Week 12, 24, 36 and 48

• laboratory test

  Week 12, 24, 36 and 48

Other Outcomes (4)

• Analysis of intestinal microbes

  Week 12

• Analysis of the association between gut microbes, brain imaging and behavior

  Week 12

• Acupuncture efficacy prediction

  Week 48

Study Arms (1)

Acupuncture group

EXPERIMENTAL

Participants receiving acupuncture and mild moxibustion.

Other: acupuncture

Interventions

acupuncture OTHER

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 acupoints was maintained at 43℃± 1℃ for moxibustIon.

Acupuncture group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 16-70;
• patients with mild or moderate active disease (150 ≤ CDAI \< 450);
• patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
• 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;
• those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
• those who have never experienced acupuncture;
• patients signing informed consent.

You may not qualify if:

• patients who are recently pregnant or in pregnancy or lactation;
• patients with serious organic diseases;
• patients diagnosed as psychosis;
• 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;
• severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
• there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
• patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
• there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Fudan University: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Indiana University School of Medicine: collaborator

Study Sites (2)

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Guona Li

Shanghai, 2000, China

RECRUITING

MeSH Terms

Conditions

Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Huangan Wu, MD, PhD

  Shanghai Research Institute of Acupuncture and Meridian

  STUDY CHAIR

Central Study Contacts

Chunhui Bao, MD, PhD

CONTACT

+862164395973; baochunhui789@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 5, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)