Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

NCT06553053 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Phase

Not applicable

Started

2024-08-13

Last updated

2026-04-13

Condition(s) studied

Crohn's Disease RelapseInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group"Nourishing spleen and kidney with warmth" Acupuncture Group

"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group: 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, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.

"Nourishing spleen and kidney with warmth" Acupuncture Group: 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 for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.

Study 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

Sex

ALL

Min age

16 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

The proportion of recurrences — Week 52
Defined as CDAI \> 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.

Trial sites (1)

Facility	City	Region	Status
Shanghai Research Institute of Acupuncture and Meridian	Shanghai	China	Recruiting

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Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06553053 on ClinicalTrials.gov ↗ ← All trials in China