Back to resultsThe Promotion Plan of Moxibustion on Ulcerate 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
About this trial
This is an interventional basic science trial for Ulcerative Colitis
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
Sites / Locations
- 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, ST37 and CV6. 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, ST37 and CV6. 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
total effective rate
The curative effect of Herb-partitioned moxibustion for 128 UC patients.
Secondary 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.
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)
Observe the degree of abdominal pain
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.
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.
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)
gut mucosal score under the endoscopy: Baron score;
evaluate the gut mucosal state by using electronic colonoscopy
mucosal pathology：Geboes score
Observe the intestinal mucosal tissue changes by HE staining
Full Information
NCT ID
NCT03232528
First Posted
July 24, 2017
Last Updated
March 17, 2021
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1. Study Identification
Unique Protocol Identification Number
NCT03232528
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
4. Oversight
5. Study Description
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.
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
128 (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, ST37 and CV6. 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, ST37 and CV6. 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
total effective rate
Description
The curative effect of Herb-partitioned moxibustion for 128 UC patients.
Time Frame
3 months
Secondary 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
6 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
Observe the degree of abdominal pain
Time Frame
6 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
6 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
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
6 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
6 months
Title
gut mucosal score under the endoscopy: Baron score;
Description
evaluate the gut mucosal state by using electronic colonoscopy
Time Frame
3 months
Title
mucosal pathology：Geboes score
Description
Observe the intestinal mucosal tissue changes by HE staining
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
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Shanghai Research Insititute of Acupuncture and Meridian
City
Shanghai
State/Province
Xuhui
ZIP/Postal Code
20000
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Promotion Plan of Moxibustion on Ulcerate Colitis
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