Ulcerative Colitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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); * 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; * genetic family history of nervous system disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total effective rate | 3 months | The curative effect of Herb-partitioned moxibustion for 128 UC patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gut mucosal score under the endoscopy: Baron score; | 3 months | evaluate the gut mucosal state by using electronic colonoscopy |
| Mayo score | 6 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. |
| symptom score | 3 months | Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score. |
| Visual Analogue Scale(VAS) | 6 months | Observe the degree of abdominal pain |
| Hospital Anxiety and Depression Scale(HADS) | 3 months | 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. |
| Laboratory tests for disease activity: C-reaction protein | 6 months | Assay for the quantification of total C-reaction protein in serum.(Normal reference value:\<10mg/L) |
| Laboratory tests for disease activity: Erythrocyte sedimentation rate | 6 months | Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h) |
| mucosal pathology：Geboes score | 3 months | Observe the intestinal mucosal tissue changes by HE staining |
| Inflammatory Bowel Disease Questionnaire(IBDQ) | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 3 months | With Administration Events reports record the adverse reaction treatment process, with the moxibustion treatment of safety evaluation. Such as the incidence and severity of scald, skin allergic, vasodepressor syncope etc. Also record subjects's vital signs, consist of body temperature, blood pressure and pulse. |
Countries
China
Outcome results
None listed