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The Effects of Moxibustion on Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Herb-partitioned moxibustion
Sham herb-partitioned moxibustion
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Herb-partitioned moxibustion

Sham herb-partitioned moxibustion

Arm Description

Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.

Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MRI
Brain structure(gray matter, white matter structures) changes examined by MRI
functional MRI
Brain resting state activity changes examined by functional MRI
mucosal pathology; Baron score;
using electronic colonoscopy
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.
Laboratory tests for disease activity: C-reaction protein
Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)
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)
The serum concentrations of 1,25-dihydroxyvitamin D3
The serum levels of 25(OH)D concentration.
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.
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 .
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
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
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
The serum levels of IL-12/23 p40
The changes of serum IL-12/23 p40 concentration before and after treatment were observed.
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.
The expression of Reg4 and VDR in mucosa
The protein expressions of Reg IV and VDR in UC colon mucosa were detected by immunohistochemistry.
The level of TNF-α, IFN-γ, IL-2 and LPS in plasma
The plasma lever of IL-2, LPS, IFN-γ and TNF-α by using ELISA method.
The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa
IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in UC colon mucosa were detected by immunohistochemistry.

Full Information

First Posted
September 25, 2016
Last Updated
March 17, 2021
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT02931162
Brief Title
The Effects of Moxibustion on Ulcerative Colitis
Official Title
Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herb-partitioned moxibustion
Arm Type
Experimental
Arm Description
Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.
Arm Title
Sham herb-partitioned moxibustion
Arm Type
Sham Comparator
Arm Description
Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.
Intervention Type
Other
Intervention Name(s)
Herb-partitioned moxibustion
Other Intervention Name(s)
Treatment Group
Intervention Description
Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Intervention Type
Other
Intervention Name(s)
Sham herb-partitioned moxibustion
Other Intervention Name(s)
Control Group
Intervention Description
Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Primary Outcome Measure Information:
Title
Mayo score
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
MRI
Description
Brain structure(gray matter, white matter structures) changes examined by MRI
Time Frame
3 months
Title
functional MRI
Description
Brain resting state activity changes examined by functional MRI
Time Frame
3 months
Title
mucosal pathology; Baron score;
Description
using electronic colonoscopy
Time Frame
3 months
Title
Inflammatory Bowel Disease Questionnaire(IBDQ)
Description
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.
Time Frame
3 months
Title
Laboratory tests for disease activity: C-reaction protein
Description
Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)
Time Frame
3 months
Title
Laboratory tests for disease activity: Erythrocyte sedimentation rate
Description
Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h)
Time Frame
3 months
Title
The serum concentrations of 1,25-dihydroxyvitamin D3
Description
The serum levels of 25(OH)D concentration.
Time Frame
3 months
Title
symptom score
Description
Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score.
Time Frame
3 months
Title
Visual Analogue Scale(VAS)
Description
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 .
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale(HADS)
Description
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
Time Frame
3 months
Title
Self-Rating Anxiety Scale(SAS)
Description
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
Time Frame
3 months
Title
Self-rating Depression Scale(SDS)
Description
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
Time Frame
3 months
Title
The serum levels of IL-12/23 p40
Description
The changes of serum IL-12/23 p40 concentration before and after treatment were observed.
Time Frame
3 months
Title
The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa
Description
The relative quantity of Cytochrome p450 27B1(Cyp27b1), Reg IV and Vdr by real-time quantitative PCR.
Time Frame
3 months
Title
The expression of Reg4 and VDR in mucosa
Description
The protein expressions of Reg IV and VDR in UC colon mucosa were detected by immunohistochemistry.
Time Frame
3 months
Title
The level of TNF-α, IFN-γ, IL-2 and LPS in plasma
Description
The plasma lever of IL-2, LPS, IFN-γ and TNF-α by using ELISA method.
Time Frame
3 months
Title
The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa
Description
IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in UC colon mucosa were detected by immunohistochemistry.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Safety Assessment
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huangan Wu, Doctor
Organizational Affiliation
Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian
City
Shanghai
State/Province
Xuhui
ZIP/Postal Code
20000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Moxibustion on Ulcerative Colitis

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