Clinical trial NCT02931162: The Effects of Moxibustion on Ulcerative Colitis
Official title: Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

Detailed description: A total of 60 patients with UC were randomly divided into the following 2 groups: a) Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. MRI will be used to observe the changes on brain structure and function in patients with UC, and further research on the characteristics of the brain nerve response of these patients with herb-partition moxibustion. In addition, tissue morphology and molecular biology tests will be conducted to observe the regulation and expression of VDR and antimicrobial peptides in the intestinal mucosa of UC patients. All these steps will be done in order to provide experimental basis for the mechanism of the effects of herb-partition moxibustion in the treatment of UC.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnosis of UC
* Mayo ≤10
* Patients do not receive any medicine, or if they are receiving medicine, it should be aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month), and must kept the same dose as before throughout the trial;
* Patients should have not received antibiotic, biologicals within 3 months prior to entering the study;
* Signing a written informed consent.

Exclusion Criteria:

* Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases;
* Pregnancy or lactation;
* The psychiatric patients;
* Current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness;
* Learning disability;
* Claustrophobia;
* Presence of metallic implants in the body;

Primary outcomes:
measure: Mayo score
timeFrame: 3 months
Secondary outcomes:
measure: MRI
timeFrame: 3 months
measure: functional MRI
timeFrame: 3 months
measure: mucosal pathology; Baron score;
timeFrame: 3 months
measure: Inflammatory Bowel Disease Questionnaire(IBDQ)
timeFrame: 3 months
measure: Laboratory tests for disease activity: C-reaction protein
timeFrame: 3 months
measure: Laboratory tests for disease activity: Erythrocyte sedimentation rate
timeFrame: 3 months
measure: The serum concentrations of 1,25-dihydroxyvitamin D3
timeFrame: 3 months
measure: symptom score
timeFrame: 3 months
measure: Visual Analogue Scale(VAS)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 3 months
measure: Self-Rating Anxiety Scale(SAS)
timeFrame: 3 months
measure: Self-rating Depression Scale(SDS)
timeFrame: 3 months
measure: The serum levels of IL-12/23 p40
timeFrame: 3 months
measure: The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa
timeFrame: 3 months
measure: The expression of Reg4 and VDR in mucosa
timeFrame: 3 months
measure: The level of TNF-α, IFN-γ, IL-2 and LPS in plasma
timeFrame: 3 months
measure: The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa
timeFrame: 3 months
Other outcomes:
measure: Safety Assessment
timeFrame: 3 months
Locations:
city: Shanghai
country: China
facility: Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian
state: Xuhui
Study officials:
affiliation: Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.
name: Huangan Wu, Doctor
role: STUDY_DIRECTOR
References: