Clinical trial NCT03232528: The Promotion Plan of Moxibustion on Ulcerate Colitis
Official title: A Study on the Promotion Plan of the Moxibustion Treatment of Ulcerate Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: total effective rate
timeFrame: 3 months
Secondary outcomes:
measure: Mayo score
timeFrame: 6 months
measure: symptom score
timeFrame: 3 months
measure: Visual Analogue Scale(VAS)
timeFrame: 6 months
measure: Inflammatory Bowel Disease Questionnaire(IBDQ)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 3 months
measure: Laboratory tests for disease activity: C-reaction protein
timeFrame: 6 months
measure: Laboratory tests for disease activity: Erythrocyte sedimentation rate
timeFrame: 6 months
measure: gut mucosal score under the endoscopy: Baron score;
timeFrame: 3 months
measure: mucosal pathology：Geboes score
timeFrame: 3 months
Other outcomes:
measure: Safety Assessment
timeFrame: 3 months
Locations:
city: Shanghai
country: China
facility: Shanghai Research Insititute of Acupuncture and Meridian
state: Xuhui
Study officials:
affiliation: Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine
name: Huangan Wu, Doctor
role: STUDY_DIRECTOR
References: