NCT06553053 Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
| NCT ID | NCT06553053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian |
| Condition | Crohn's Disease Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2024-08-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
Eligibility Criteria
Inclusion Criteria: 1. patients with clinical diagnosis consistent with CD; 2. aged 16-75; 3. patients in remission (CDAI \< 150 and CRP \< 5mg/l, or Faecal calprotectin \< 50μg/g, or no ulcer under endoscopy); 4. patients with frequent disease recurrences (≥2) in the past years; 5. patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7); 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 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.
Contact & Investigator
Bao Chunhui, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai University of TCM
Frequently Asked Questions
Who can join the NCT06553053 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 75 Years, studying Crohn's Disease Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06553053 currently recruiting?
Yes, NCT06553053 is actively recruiting participants. Contact the research team at baochunhui789@126.com for enrollment information.
Where is the NCT06553053 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06553053 clinical trial?
NCT06553053 is sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian. The principal investigator is Bao Chunhui, MD, PhD at Shanghai University of TCM. The trial plans to enroll 106 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.