The Promotion Plan of Moxibustion on Ulcerate Colitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study on the Promotion Plan of the Moxibustion Treatment of Ulcerate Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Herb-partitioned moxibustion
* Other: Sham herb-partitioned moxibustion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herb-partitioned moxibustion<br>Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks. | Other: Herb-partitioned moxibustion<br>* Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.<br>* Other names: Treatment Group;|
| Sham Comparator: Sham herb-partitioned moxibustion<br>Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks. | Other: Sham herb-partitioned moxibustion<br>* Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total effective rate | The curative effect of Herb-partitioned moxibustion for 128 UC patients. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months | 
| Visual Analogue Scale(VAS) | Observe the degree of abdominal pain | 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. | 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. | 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) | 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) | 6 months | 
| gut mucosal score under the endoscopy: Baron score; | evaluate the gut mucosal state by using electronic colonoscopy | 3 months | 
| mucosal pathology：Geboes score | Observe the intestinal mucosal tissue changes by HE staining | 3 months |