To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the scientific foundation for rational use of Moxibustion in clinical usage, in order to find admission of the Acupuncture and Moxibustion and even medicine field, accomplish popularization and application.
A total of 128 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. After treating the treatment had ended and the 52nd week of follow-up to observe the clinical therapy effect of Moxibustion in UC patients. Tissue morphology and molecular biology tests will be conducted to observe the regulation in the intestinal mucosa of UC patients. All these steps will be done in order to provide clinical usage for the effects of herb-partition moxibustion in the treatment of UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
128
Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Shanghai Research Insititute of Acupuncture and Meridian
Shanghai, Xuhui, China
total effective rate
The curative effect of Herb-partitioned moxibustion for 128 UC patients.
Time frame: 3 months
Mayo score
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.
Time frame: 6 months
symptom score
Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score.
Time frame: 3 months
Visual Analogue Scale(VAS)
Observe the degree of abdominal pain
Time frame: 6 months
Inflammatory Bowel Disease Questionnaire(IBDQ)
Life quality was determined by the total score of the 32 questions. Each question is given 1-7 different degrees of answer. One represents the heaviest degree and seven represents the lightest degree. The lower the score (minimum 32 points and maximum 224 points), the worse the life quality.
Time frame: 6 months
Hospital Anxiety and Depression Scale(HADS)
The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 .The higher the total score (minimum 0 point and maximum 21 points), the more severe the anxiety or depression.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months
Laboratory tests for disease activity: C-reaction protein
Assay for the quantification of total C-reaction protein in serum.(Normal reference value:\<10mg/L)
Time frame: 6 months
Laboratory tests for disease activity: Erythrocyte sedimentation rate
Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0~15mm/h; female 0~20mm/h)
Time frame: 6 months
gut mucosal score under the endoscopy: Baron score;
evaluate the gut mucosal state by using electronic colonoscopy
Time frame: 3 months
mucosal pathology:Geboes score
Observe the intestinal mucosal tissue changes by HE staining
Time frame: 3 months