Crohn'sRecruiting

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

Not applicable · Testing acupuncture · 2 sites · Shanghai Institute of Acupuncture, Moxibustion and Meridian

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing acupuncture as a possible treatment. Condition(s) listed: Intestinal Disorder, Inflammatory Bowel Diseases and Crohn Disease.

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 16 to 70
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

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;

Plus 4 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 60 participants are expected to take part.
Start date: 2019-06-01.
Main results expected around 2026-12-31 (estimate from the record).
2 study sites listed (2 marked recruiting) in China.

Main thing being measured

Clinical remission (Week 12)

In the researchers’ words

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

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Intestinal Disorder; Inflammatory Bowel Diseases; Crohn Disease
Lead sponsor	Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators	Fudan University; Shanghai University of Traditional Chinese Medicine; Shanghai Jiao Tong University School of Medicine; Indiana University
Enrollment	60 (estimated)
Start date	2019-06-01
Primary completion (est.)	2026-12-31
First posted	2019-12-05
Last updated	2025-05-14
Official title	Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
ClinicalTrials.gov ID	NCT04187820

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…

Full eligibility criteria (from the record)

Inclusion Criteria:

1. aged 16-70;
2. patients with mild or moderate active disease (150 ≤ CDAI < 450);
3. patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
4. 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;
5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
6. those who have never experienced acupuncture;
7. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. 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;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Locations (2)

Site	City	Country	Site status
Guona Li	Shanghai	China	Recruiting
Shanghai Research Institute of Acupuncture and Meridian	Shanghai, Shanghai Municipality	China	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.