Back to resultsMoxibustion for Mild and Moderate Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
herb-partitioned moxibustion
bran-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
- Mayo ≤10
- Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
- Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
- A written informed consent
Exclusion Criteria:
- Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
- Pregnancy or lactation
Sites / Locations
- Shanghai Institute of Acupuncture-Moxibustion and Meridian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
moxibustion group
bran-partitioned moxibustion
Arm Description
herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
Outcomes
Primary Outcome Measures
disease activity index (DAI)
Using Mayo subscore
Secondary Outcome Measures
Inflammatory Bowel Disease Questionnaire (IBDQ)
symptom score
histomorphology observation of intestinal mucosa
Using the Geboes histology score
metabolic profile of intestinal mucosa, urine, plasma and serum
Full Information
NCT ID
NCT02084186
First Posted
March 9, 2014
Last Updated
October 10, 2016
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1. Study Identification
Unique Protocol Identification Number
NCT02084186
Brief Title
Moxibustion for Mild and Moderate Ulcerative Colitis
Official Title
The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (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
The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.
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
moxibustion group
Arm Type
Experimental
Arm Description
herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
Arm Title
bran-partitioned moxibustion
Arm Type
Placebo Comparator
Arm Description
bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
Intervention Type
Other
Intervention Name(s)
herb-partitioned moxibustion
Intervention Description
Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
Intervention Type
Other
Intervention Name(s)
bran-partitioned moxibustion
Intervention Description
Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
Primary Outcome Measure Information:
Title
disease activity index (DAI)
Description
Using Mayo subscore
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
3 months
Title
symptom score
Time Frame
3 months
Title
histomorphology observation of intestinal mucosa
Description
Using the Geboes histology score
Time Frame
3 months
Title
metabolic profile of intestinal mucosa, urine, plasma and serum
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
Mayo ≤10
Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
A written informed consent
Exclusion Criteria:
Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
Pregnancy or lactation
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 Institute of Acupuncture-Moxibustion and Meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Learn more about this trial
Moxibustion for Mild and Moderate Ulcerative Colitis
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