NCT02559037

Brief Summary

The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

April 7, 2020

Status Verified

December 1, 2019

Enrollment Period

3.8 years

First QC Date

April 16, 2015

Last Update Submit

April 3, 2020

Conditions

Crohn's Disease

Keywords

acupuncturemoxibustionintestinal microbiotaPeripheral immunityBrain functional and structural changes

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with clinical remission

    Defined as Crohn's disease activity Index (CDAI) \< 150 and decrease \> 70

    Week 12

Secondary Outcomes (14)

  • The proportion of patients with clinical remission

    Week 24, 36 and 48

  • The proportion of patients with clinical response

    Week 12, 24, 36 and 48

  • the mean change of CDAI from baseline

    Week 12, 24, 36 and 48

  • Laboratory tests for disease activity

    Week 12, 24, 36 and 48

  • Laboratory tests for disease activity

    Week 12, 24, 36 and 48

  • +9 more secondary outcomes

Other Outcomes (8)

  • Intestinal microbiota

    Week 12

  • Plasma inflammatory cytokine levels

    Week 12

  • Intestinal barrier function

    Week 12

  • +5 more other outcomes

Study Arms (2)

Acupuncture-moxibustion group

EXPERIMENTAL

Receiving acupuncture and moxibustion treatment.

Device: Acupuncture and moxibustion

Sham acupuncture-moxibustion group

SHAM COMPARATOR

Receiving sham acupuncture and sham moxibustion.

Device: Sham acupuncture and moxibustion

Interventions

Acupuncture and moxibustionDEVICE

Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30\*40mm or 0.30\*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min. Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Acupuncture-moxibustion group
Sham acupuncture and moxibustionDEVICE

The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 \* 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation. Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Sham acupuncture-moxibustion group

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • meet the diagnostic criteria of Crohn's disease;
  • age 16-70 years old;
  • patients with mild or moderate disease (150\<CDAI\<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
  • patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
  • did not take or take one or more of the following drugs: prednisone \<15 mg/d for at least one month, azathioprine (\<1 mg/kg/d), methotrexate (\<15 mg/week), or mesalazine (\<4 g/d) for at least 3 months;
  • no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
  • no previous history of receiving acupuncture;
  • provision of written informed consent.

You may not qualify if:

  • Pregnant or lactating women, and those desirous of conceiving in the near future;
  • patients with severe organic diseases;
  • patients with mental illness;
  • patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
  • patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
  • patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
  • severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
  • patients with short bowel syndrome;
  • patients with a history of abdominal or gastrointestinal surgery in the past six months;
  • patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

  • Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.

    PMID: 35198926DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Acupuncture TherapyMoxibustion

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Huangan Wu, MD,PhD

    Shanghai University of TCM

    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

April 16, 2015

First Posted

September 24, 2015

Study Start

April 1, 2015

Primary Completion

December 31, 2018

Study Completion

November 30, 2019

Last Updated

April 7, 2020

Record last verified: 2019-12

Locations

CN(1)