Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-75
SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
patients with frequent disease recurrences (≥2) in the past years;
Disqualifiers
patients who are recently pregnant or in pregnancy or lactation;
patients with serious organic diseases;
patients diagnosed as psychosis;
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;
Trial design
Design model
Parallel
Treatments tested in this trial
"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group
Other interventionPatients 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 interventionPatients 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 52Secondary outcomes
1
Number of recurrences
Total number of recurrences. The median number will be counted for both groups.
Time frame
Week 522
Time of recurrences
Time to first recurrence will be counted for both groups.
Time frame
Week 523
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.
Time frame
Week 0, 6, 12, 24, 36 and 524
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.
Time frame
Week 0, 6, 12, 24, 36 and 52Other outcomes
1
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.
Time frame
Week 0 and 122
Salivary cortisol
Salivary cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Time frame
Week 0 and 123
α-Salivary Amylase
α-Salivary Amylase is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Time frame
Week 0 and 124
Serum cortisol
Serum cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function.
Time frame
Week 0 and 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Lead sponsor
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov