NCT06352164Completed
Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease
Predicting the Clinical Efficacy of Acupuncture for Abdominal Pain in Patients With Crohn's Disease Based on Gut Microbiology and Machine Learning
Source: ClinicalTrials.gov · Last updated 9 Apr 2024
Brief summary (registry, in English)
Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 2 Apr 2024
- Start date
- 1 Mar 2015
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Diseases
- Crohn's disease
- NCT number
- NCT06352164
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 1 Mar 2015 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- patients with serious organic diseases;
- patients 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.
Other
- patients who are recently pregnant or in pregnancy or lactation;
- patients diagnosed as psychosis;
Who the study is looking for
- aged 18-75, no gender limit;
- disease in mild and moderate active period: 150≤CDAI\<450 and meet at least one of the following: Serum C-reactive protein level≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI \<150 and meet at least one of the following: Serum C-reactive protein level\<5 mg/L, Fecal calprotectin concentration \<250μg/g or endoscopic examination shows no ulcer;
- patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
- those who have not used biologics within 3 months before entering the study;
- those who have never experienced acupuncture;
- those who understand and agree to participate in this study and sign the informed consent form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Institute of Acupuncture, Moxibustion and Meridian Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.