Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Mayo score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Meet the diagnosis of UC
- •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;
Outcomes
Primary Outcomes
Mayo score
Time Frame: 3 months
Assay for the ulcerative colitis desease activity index. It is constructed by four scales, Including stool frequency、rectal bleeding、mucosal appearance at endoscopy and physician rating of disease activity. Every scale can be scored with o ,1 ,2 or 3 according to the activity index of scale. Scores should be compared to previous scores taken for a patient. The higher the score (minimum 0 point and maximum 12 points), the more severe the ulcerative colitis.
Secondary Outcomes
- Inflammatory Bowel Disease Questionnaire(IBDQ)(3 months)
- Hospital Anxiety and Depression Scale(HADS)(3 months)
- Laboratory tests for disease activity: C-reaction protein(3 months)
- The serum concentrations of 1,25-dihydroxyvitamin D3(3 months)
- The serum levels of IL-12/23 p40(3 months)
- functional MRI(3 months)
- mucosal pathology; Baron score;(3 months)
- Laboratory tests for disease activity: Erythrocyte sedimentation rate(3 months)
- MRI(3 months)
- symptom score(3 months)
- Self-Rating Anxiety Scale(SAS)(3 months)
- The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa(3 months)
- The level of TNF-α, IFN-γ, IL-2 and LPS in plasma(3 months)
- Visual Analogue Scale(VAS)(3 months)
- Self-rating Depression Scale(SDS)(3 months)
- The expression of Reg4 and VDR in mucosa(3 months)
- The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa(3 months)