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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04187820
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Institute of Acupuncture, Moxibustion and Meridian
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Huangan Wu, MD, PhD
Principal Investigator Affiliation Shanghai Research Institute of Acupuncture and Meridian
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease
Additional Details

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

Arms & Interventions

Arms

Experimental: Acupuncture group

Participants receiving acupuncture and mild moxibustion.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, Shanghai, 200030

Site Contact

Chunhui Bao, Doctor

baochunhui789@126.com

+862164395973

Guona Li, Shanghai, China

Status

Recruiting

Address

Guona Li

Shanghai, , 2000

Site Contact

Guona Li

liguonaaa@163.com

+862465161782