A Study on the Promotion Plan of the Moxibustion Treatment of Ulcerate Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- total effective rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 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);
- •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
Outcomes
Primary Outcomes
total effective rate
Time Frame: 3 months
The curative effect of Herb-partitioned moxibustion for 128 UC patients.
Secondary Outcomes
- Mayo score(6 months)
- Laboratory tests for disease activity: Erythrocyte sedimentation rate(6 months)
- Visual Analogue Scale(VAS)(6 months)
- Hospital Anxiety and Depression Scale(HADS)(3 months)
- symptom score(3 months)
- Inflammatory Bowel Disease Questionnaire(IBDQ)(6 months)
- Laboratory tests for disease activity: C-reaction protein(6 months)
- gut mucosal score under the endoscopy: Baron score;(3 months)
- mucosal pathology：Geboes score(3 months)