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Recruiting NCT04187820

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

No phase Interventional Intestinal Disorder Inflammatory Bowel Diseases Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acupuncture.
Who it may be relevant to
Registry conditions: Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease. Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Overview

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

Detailed description

1. Effect of acupuncture on symptoms of CD 2. Effect of acupuncture on brain functional activity of CD 3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD 4. Screen the brain image markers of acupuncture in the treatment of CD

Interventions

  • Other acupuncture
    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.

Primary outcome measures

  • Clinical remission [Time frame: Week 12]
Secondary outcome measures (12)
  • Clinical remission [Time frame: Week 24, 36 and 48]
  • Clinical response [Time frame: Week 12, 24, 36 and 48]
  • Crohn's disease activity index （CDAI）score [Time frame: Week 12, 24, 36 and 48]
  • laboratory test [Time frame: Week 12, 24, 36 and 48]
  • laboratory test [Time frame: Week 12, 24, 36 and 48]
  • laboratory test [Time frame: Week 12, 24, 36 and 48]
  • Inflammatory bowel disease questionnaire (IBDQ) [Time frame: Week 12 and 24]
  • Crohn's disease endoscopic index of severity (CDEIS) [Time frame: Week 48]
  • Hospital anxiety and depression scale (HADS) [Time frame: Week 12 and 24]
  • The proportion of recurrences [Time frame: Week 48]
  • Brain functional and structural changes [Time frame: Week 12]
  • Plasma and intestinal TRP-KYN metabolism level [Time frame: Week 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Shanghai Research Institute of Acupuncture and Meridian — Shanghai
  • Guona Li — Shanghai

Identifiers

NCT: NCT04187820 · ZYS2019-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗