To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD
1. Effect of acupuncture on symptoms of CD 2. Effect of acupuncture on brain functional activity of CD 3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD 4. Screen the brain image markers of acupuncture in the treatment of CD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, Shanghai Municipality, China
RECRUITINGGuona Li
Shanghai, China
RECRUITINGClinical remission
Crohn's disease activity index (CDAI)less than 150 and decreased more than 70
Time frame: Week 12
Clinical remission
Crohn's disease activity index (CDAI) less than 150 and decreased more than 70
Time frame: Week 24, 36 and 48
Clinical response
Crohn's disease activity index (CDAI) decreased more than 70
Time frame: Week 12, 24, 36 and 48
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 12, 24, 36 and 48
laboratory test
serum C-reactive protein (CRP) level
Time frame: Week 12, 24, 36 and 48
laboratory test
Erythrocyte sedimentation rate (ESR)
Time frame: Week 12, 24, 36 and 48
laboratory test
Platelet count
Time frame: Week 12, 24, 36 and 48
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.
Time frame: Week 12 and 24
Crohn's disease endoscopic index of severity (CDEIS)
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The mean change in CDEIS from baseline
Time frame: Week 48
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.
Time frame: Week 12 and 24
The proportion of recurrences
Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Time frame: Week 48
Brain functional and structural changes
measured by functional MRI
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Indoleamine2,3dioxygenase 1 (IDO1)level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Tryptophan (TRP) level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenine (KYN)level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenic acid (KYNA) level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal quinolinic acid (QUIN) level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IFN-gamma level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-1beta level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-18 level
Time frame: Week 12