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

Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study ID
NCT06553053
Status
Recruiting
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Conditions

  • Crohn's Disease Relapse
  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

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, 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 — 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 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 Details

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.

Key Dates

First listed
Aug 14, 2024
Start date
Aug 13, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth"
  • Active Comparator: Control group
    Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth"

Primary Outcome Measure

The proportion of recurrences [ Time Frame: Week 52 ]

Central Contacts

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