The Effects of Moxibustion on Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931162
• Other study ID #: UC-Brain
• Status: Completed
• Phase: N/A
• Start date: August 23, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

Description:

A total of 60 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. MRI will be used to observe the changes on brain structure and function in patients with UC, and further research on the characteristics of the brain nerve response of these patients with herb-partition moxibustion. In addition, tissue morphology and molecular biology tests will be conducted to observe the regulation and expression of VDR and antimicrobial peptides in the intestinal mucosa of UC patients. All these steps will be done in order to provide experimental basis for the mechanism of the effects of herb-partition moxibustion in the treatment of UC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Meet the diagnosis of UC

• Mayo =10

• 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), and must kept the same dose as before throughout the trial;

• 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;

• The psychiatric patients;

• Current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness;

• Learning disability;

• Claustrophobia;

• Presence of metallic implants in the body;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• 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	Outpatient department of 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	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.	3 months
Secondary	MRI	Brain structure(gray matter, white matter structures) changes examined by MRI	3 months
Secondary	functional MRI	Brain resting state activity changes examined by functional MRI	3 months
Secondary	mucosal pathology; Baron score;	using electronic colonoscopy	3 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.	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)	3 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)	3 months
Secondary	The serum concentrations of 1,25-dihydroxyvitamin D3	The serum levels of 25(OH)D concentration.	3 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)	Obserb the degree of abdominal pain and ventosity. Draw a 10 cm horizontal line on the paper, one end of which is 0, indicating no pain; The other end is 10, which means pain; The middle part indicates different degrees of pain. Ask the patient to make a mark on the line to indicate the degree of pain based on how he or she feels. The mean value of mild pain was 2.57 + / - 1.04. The mean of moderate pain was 5.18 + / - 1.41. The mean value of severe pain was 8.41 + / - 1.35 .	3 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	Self-Rating Anxiety Scale(SAS)	The SAS is a 20-item self-report assessment device built to measure anxiety levels. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time," "some of the time," "good part of the time," "most of the time").The total raw scores range from 20-80.The raw score then needs to be converted to an "Anxiety Index" score using the chart on the paper version of the test that can be found on the link below. The "Anxiety Index" score can then be used on this scale below to determine the clinical interpretation of one's level of anxiety: 20-44 Normal Range 45-59 Mild to Moderate Anxiety Levels 60-74 Marked to Severe Anxiety Levels 75 and above Extreme Anxiety Levels	3 months
Secondary	Self-rating Depression Scale(SDS)	The SDS is a 20-item self-report assessment device built to measure depression levels. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time," "some of the time," "good part of the time," "most of the time").The total raw scores range from 20-80.The raw score then needs to be converted to an "Depression Index" score using the chart on the paper version of the test that can be found on the link below. The "Depression Index" score can then be used on this scale below to determine the clinical interpretation of one's level of anxiety: 20-44 Normal Range 45-59 Mild to Moderate Depression Levels 60-74 Marked to Severe Depression Levels 75 and above Extreme Depression Levels	3 months
Secondary	The serum levels of IL-12/23 p40	The changes of serum IL-12/23 p40 concentration before and after treatment were observed.	3 months
Secondary	The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa	The relative quantity of Cytochrome p450 27B1(Cyp27b1), Reg IV and Vdr by real-time quantitative PCR.	3 months
Secondary	The expression of Reg4 and VDR in mucosa	The protein expressions of Reg IV and VDR in UC colon mucosa were detected by immunohistochemistry.	3 months
Secondary	The level of TNF-a, IFN-?, IL-2 and LPS in plasma	The plasma lever of IL-2, LPS, IFN-? and TNF-a by using ELISA method.	3 months
Secondary	The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-?B in mucosa	IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-?B in UC colon mucosa were detected by immunohistochemistry.	3 months