Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
NCT Number: NCT06553053
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crohn's Disease Relapse|Inflammatory Bowel Diseases
Interventions: OTHER: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group|OTHER: "Nourishing spleen and kidney with warmth" Acupuncture Group
Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators: Ruijin Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2028-12-31
Locations: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China

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.

Primary Outcome Measures: The proportion of recurrences, 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., Week 52
Secondary Outcome Measures: Number of recurrences, Total number of recurrences. The median number will be counted for both groups., Week 52|Time of recurrences, Time to first recurrence will be counted for both groups., Week 52|Crohn's disease activity index （CDAI）score, The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit., Week 0, 6, 12, 24, 36 and 52|Patient Reported Outcome （PRO2）, The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week., Week 0, 6, 12, 24, 36 and 52|First laboratory tests, serum C-reactive protein (CRP), Week 0, 6, 12, 24, 36 and 52|Second laboratory tests, erythrocyte sedimentation rate (ESR), Week 0, 6, 12, 24, 36 and 52|Third laboratory tests, platelet count (PLT), Week 0, 6, 12, 24, 36 and 52|Inflammatory bowel disease questionnaire (IBDQ), The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224., Week 0, 12, 24, 36 and 52|Hospital anxiety and depression scale (HADS), The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21., Week 0, 12, 24, 36 and 52|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52., Week 0, 12, 24, 36 and 52|Colonoscopy or small bowel MR evaluation, measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score), Week 0 and 52|Expectation of acupuncture treatment, measured by acupuncture treatment effectiveness expectation questionnaire, Week 0|Blind questionnaire, measured by patients guessing their grouping, Week 6 and 12
Other Outcome Measures: Effects of acupuncture on brain network connectivity properties, Gray matter structure of the brain，functional connectivity and network properties of brain networks and local activity in brain regions were measured in an attempt to analyze the correlation between changes in these indicators after acupuncture intervention and the efficacy of acupuncture., Week 0 and 12|Salivary cortisol, Salivary cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function., Week 0 and 12|α-Salivary Amylase, α-Salivary Amylase is measured by ELISA to analyze effect of acupuncture on HPA axis function., Week 0 and 12|Serum cortisol, Serum cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function., Week 0 and 12|Effect of acupuncture on autonomic nervous activity, The effect of acupuncture on autonomic function was recorded by DMS300-4AL., Week 0 and 12|Effect of acupuncture on intestinal inflammation levels function, Intestinal inflammation levels are measured by C-reactive protein and plasma concentrations of tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and IL-6., Week 0 and 12|Effect of acupuncture on intestinal mucosal barrier function, Intestinal mucosal barrier function are measured by concentrations of lipopolysaccharide (LPS), Diamine oxidase (DAO) and D-lactate., Week 0 and 12