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

NCT04211129 | Suspended DMC

• 1 other identifier: ZYS2019-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Keywords

acupuncture; Crohn's disease; brain functional activity

Outcome Measures

Primary Outcomes (1)

• Brief Fatigue Inventory (BFI-C)

  The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.

  Week 12

Secondary Outcomes (11)

• Brief Fatigue Inventory (BFI-C)

  Week 24,52

• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  Week 12, 24,52

• Crohn's disease activity index （CDAI）score

  Week 12, 24,36,48,52

• Inflammatory bowel disease questionnaire (IBDQ)

  Week 12, 24 and 52

• Hospital anxiety and depression scale (HADS)

  Week 12, 24 and 52

Study Arms (2)

acupuncture group

EXPERIMENTAL

Receiving acupuncture and moxibustion

Other: acupuncture

sham acupuncture group

SHAM COMPARATOR

Receiving sham acupuncture and sham moxibustion

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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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 in remission (CDAI \< 150);
• 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 TNF alpha and other preparations 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
• Ruijin Hospital: collaborator
• Shanghai Mental Health Center: collaborator
• Indiana University School of Medicine: collaborator

Study Sites (2)

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, 200030, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine

Shanghai, 200437, China

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

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 22, 2019
• First Posted: December 26, 2019
• Study Start: July 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)