Ulcerative ColitisNCT02931162
The Effects of Moxibustion on Ulcerative Colitis
A study testing Herb-partitioned moxibustion in people with Ulcerative Colitis, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Herb-partitioned moxibustion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian
Shanghai, Xuhui, 20000
About this study
Official title: Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Herb-partitioned moxibustion, Sham herb-partitioned moxibustion
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herb-partitioned moxibustionOther
Also called Treatment Group
Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
Sham herb-partitioned moxibustionOther
Also called Control Group
Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Herb-partitioned moxibustion | Experimental | 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. Receives: Other: Herb-partitioned moxibustion |
| Sham herb-partitioned moxibustion | Sham comparator | 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. Receives: Other: Sham herb-partitioned moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (17)
MRI
Brain structure(gray matter, white matter structures) changes examined by MRI
Measured: 3 months
functional MRI
Brain resting state activity changes examined by functional MRI
Measured: 3 months
mucosal pathology; Baron score;
using electronic colonoscopy
Measured: 3 months
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.
Measured: 3 months
Laboratory tests for disease activity: C-reaction protein
Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)
Measured: 3 months
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)
Measured: 3 months
The serum concentrations of 1,25-dihydroxyvitamin D3
The serum levels of 25(OH)D concentration.
Measured: 3 months
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.
Measured: 3 months
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 .
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
The serum levels of IL-12/23 p40
The changes of serum IL-12/23 p40 concentration before and after treatment were observed.
Measured: 3 months
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.
Measured: 3 months
The expression of Reg4 and VDR in mucosa
The protein expressions of Reg IV and VDR in UC colon mucosa were detected by immunohistochemistry.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start23 Aug 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, Doctor, Study director, Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931162
- Sponsor's protocol ID
- UC-Brain
- Status last verified
- Jun 2018
- First submitted
- 25 Sep 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02931162
- Acronym / sponsor ID
- UC-Brain
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herb-partitioned moxibustion | Experimental | Other: Herb-partitioned moxibustionDrug: 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. |
| Sham herb-partitioned moxibustion | Sham comparator | Other: Sham herb-partitioned moxibustionDrug: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herb-partitioned moxibustionAlso: Treatment GroupPatients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. | Other | Herb-partitioned moxibustion |
| Sham herb-partitioned moxibustionAlso: Control GroupPatients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. | Other | Sham herb-partitioned moxibustion |
Primary outcome
Mayo score
Time frame: 3 months
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.
17 secondary outcomes
MRI
Time frame: 3 months
functional MRI
Time frame: 3 months
mucosal pathology; Baron score;
Time frame: 3 months
Inflammatory Bowel Disease Questionnaire(IBDQ)
Time frame: 3 months
Laboratory tests for disease activity: C-reaction protein
Time frame: 3 months
Laboratory tests for disease activity: Erythrocyte sedimentation rate
Time frame: 3 months
The serum concentrations of 1,25-dihydroxyvitamin D3
Time frame: 3 months
symptom score
Time frame: 3 months
Visual Analogue Scale(VAS)
Time frame: 3 months
Hospital Anxiety and Depression Scale(HADS)
Time frame: 3 months
Self-Rating Anxiety Scale(SAS)
Time frame: 3 months
Self-rating Depression Scale(SDS)
Time frame: 3 months
The serum levels of IL-12/23 p40
Time frame: 3 months
The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa
Time frame: 3 months
The expression of Reg4 and VDR in mucosa
Time frame: 3 months
The level of TNF-α, IFN-γ, IL-2 and LPS in plasma
Time frame: 3 months
The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huangan Wu, Doctor study director
Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herb-partitioned moxibustion in people with Ulcerative Colitis, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.