The Promotion Plan of Moxibustion on Ulcerate Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232528
• Other study ID #: promotion
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2021
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Other:
• Herb-partitioned moxibustion
Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
• Sham herb-partitioned moxibustion
Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.

Locations

Country	Name	City	State
China	Shanghai Research Insititute of Acupuncture and Meridian	Shanghai	Xuhui

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Assessment	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.	3 months
Primary	total effective rate	The curative effect of Herb-partitioned moxibustion for 128 UC patients.	3 months
Secondary	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
Secondary	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
Secondary	Visual Analogue Scale(VAS)	Observe the degree of abdominal pain	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	gut mucosal score under the endoscopy: Baron score;	evaluate the gut mucosal state by using electronic colonoscopy	3 months
Secondary	mucosal pathology:Geboes score	Observe the intestinal mucosal tissue changes by HE staining	3 months