Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Not applicable · Testing "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group and… · 1 site · 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 "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group and "Nourishing spleen and kidney with warmth" Acupuncture Group as a possible treatment. Condition(s) listed: Crohn's Disease Relapse and Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
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 75
- Any sex
Some of the main requirements, copied from the record:
- patients with clinical diagnosis consistent with CD;
- aged 16-75;
- patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
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 106 participants are expected to take part.
- Start date: 2024-08-13.
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The proportion of recurrences (Week 52)
In the researchers’ words
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.
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 | Crohn's Disease Relapse; Inflammatory Bowel Diseases |
| Lead sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian |
| Collaborators | Ruijin Hospital |
| Enrollment | 106 (estimated) |
| Start date | 2024-08-13 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2024-08-14 |
| Last updated | 2026-04-13 |
| Official title | Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial |
| ClinicalTrials.gov ID | NCT06553053 |
Interventions
- "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group (Other)
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI… - "Nourishing spleen and kidney with warmth" Acupuncture Group (Other)
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected f…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Shanghai | 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.