Effect of Acupuncture on Quiescent Crohn's Disease

NCT04198831 | Completed DMC

• 1 other identifier: ZYS2015-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the clinical effect of acupuncture on quiescent Crohn's disease

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Keywords

acupuncture; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• The proportion of clinical relapse rates

  Defined as a CDAI score of \>150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.

  Week 48

Secondary Outcomes (8)

• Time of first relapse

  Week 48

• Number of relapses

  Week 48

• Moderate to severe clinical relapse rate

  Week 48

• The mean change of CDAI from baseline

  Week 12, 24, 36 and 48

• The mean change of serum CRP level from baseline

  Week 12, 24, 36 and 48

Other Outcomes (5)

• brain structural and functional changes

  Week 12

• Intestinal microbiota

  Week 12

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

  Week 12

Study Arms (2)

acupuncture group

EXPERIMENTAL

Receiving acupuncture and moxibustion treatment

Other: acupuncture

sham acupuncture group

SHAM COMPARATOR

Receiving sham acupuncture and sham moxibustion treatment

Other: Sham 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. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. 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

Sham acupuncture OTHER

Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.

sham 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 disease in remission: CDAI \<150 and at least one of the following: serum C-reactive protein \<5mg/L, fecal calprotectin \<50μg/g or no ulcers on endoscopy;
• Patients with more than 2 disease relapses in the past year;
• 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
• Ruijin Hospital: collaborator
• Indiana University School of Medicine: collaborator

Study Sites (1)

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Huangan Wu, MD, PhD

  Shanghai Research Institute of Acupuncture and Meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: April 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)