Moxibustion for Mild and Moderate Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.

Official Title
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The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: herb-partitioned moxibustion
* Other: bran-partitioned moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnosis of UC Mayo ≤10 Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial) Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive. A written informed consent Exclusion Criteria: Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases Pregnancy or lactation

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: moxibustion group<br>herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) | Other: herb-partitioned moxibustion<br>* Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.<br>|
| Placebo Comparator: bran-partitioned moxibustion<br>bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) | Other: bran-partitioned moxibustion<br>* Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease activity index (DAI) | Using Mayo subscore | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Bowel Disease Questionnaire (IBDQ) |  | 3 months | 
| symptom score |  | 3 months | 
| histomorphology observation of intestinal mucosa | Using the Geboes histology score | 3 months | 
| metabolic profile of intestinal mucosa, urine, plasma and serum |  | 3 months |